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 2
Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
Code information
Product Order Number 112-6966; Lot Number C4211-3; UPC Code *+H65811269662O*; Expiration Date September 2015.
Distribution pattern
Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.
device · product 2 of 2
Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert.
