Home › NUSMILE, LTD. › NuSmile NuNamel Pit & Fissure Sealant
NuSmile NuNamel Pit & Fissure Sealant
NUSMILE, LTD. · Model NNSPK · UDI-DI 00810118106477
1
510(k) clearances
57
Adverse events
3
Recalls
91
Facilities
Description
NuNamel Pit & Fissure Sealant 4 x 1.2 ml syringe + 20 tips Professional Kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-11-17 | Ultradent Products, Inc. | There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode |
| 2016-02-12 | Ivoclar Vivadent, Inc. | Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the pro |
| 2015-10-07 | Ivoclar A. G. | A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in d |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.