Home › Luxcreo Inc › LuxCreo DentalNight Guard Resin
LuxCreo DentalNight Guard Resin
Luxcreo Inc · Model 0.5kg/Bottle · UDI-DI 00860010425473
1
510(k) clearances
586
Adverse events
2
Recalls
82
Facilities
Description
Product Name:LuxCreo DentalNight Guard Resin;ModelNumbers:0.5kg/Bottle,K230592
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-20 | Keystone Industries | Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with |
| 2021-06-25 | Straumann USA LLC | Product label intended for the European community was distributed to the USA market via their US distribution organization |
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.