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 5
Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Code information
Lot numbers BCDZQ, BCPRC, and BD3MT
Distribution pattern
Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
device · product 2 of 5
Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Code information
Lot numbers BD96Z, BDTDM, and BDTQ6
Distribution pattern
Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
device · product 3 of 5
Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Code information
Lot numbers BC8MS, BCBHD, and BDQJ6
Distribution pattern
Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
device · product 4 of 5
Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Code information
Lot numbers BDB9Q, BDHWK, BDTBJ, and BDX3F
Distribution pattern
Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
device · product 5 of 5
Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Code information
Lot numbers BCKKP, BD2D4, BD8BY, BDH3Q, and BDTBL
Distribution pattern
Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
