Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
Regulation 872.3660
4510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SHI
| Company | 510(k)s | Recalls |
|---|---|---|
| ClearClub | 1 | 0 |
| Encore Guards | 1 | 0 |
| Grindguard, Inc. | 1 | 0 |
| Sleepcare, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 20, 2026 | K262421 | Daybreak Impression Material Sleepcare, LLC | SHI |
| Sep 16, 2026 | K261888 | ClearClub Impression Material ClearClub | SHI |
| Mar 17, 2026 | K251926 | enCore Impression Material Encore Guards | SHI |
| Feb 25, 2026 | K251724 | Remi Impression Material Grindguard, Inc. | SHI |
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