openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228842, 1230153
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 2 of 23
CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228885 1229618 1230155 1230308
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 3 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number: IEHA346
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228247
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 4 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228667
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 5 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA354
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228687, 1229554, 1229555
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 6 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228605
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 7 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1227135, 1228599
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 8 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228625, 1229564
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 9 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228703
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 10 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228602
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 11 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1229560
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 13 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228840
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 14 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA464
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1229063 1229569
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 15 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228704
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 16 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228899
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 17 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228597 1228828 1230625
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 18 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228904 1230638
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 19 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228593 1230791
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 20 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228628 1230644 1232164 1232542 1232758
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 21 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228628 1230644 1232164 1232542 1232758
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 22 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1228701 1230640 1232762
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
device · product 23 of 23
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
These labels are deterministic app interpretations, not FDA categories.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Code information
Lot Numbers: 1229061
Distribution pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
