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 3
DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Code information
Work Order (lot): 1619 and 1620
Distribution pattern
US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH
device · product 2 of 3
DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Code information
Work Order (lot): 1616, 1621, and 1622
Distribution pattern
US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH
device · product 3 of 3
DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
