SHI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3660
- Medical specialty
- Dental
- FDA definition
- An over-the-counter device that is intended to reproduce the structure of a patient's teeth and gums for the fabrication of patient-matched mouthguards/nightguards.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| enCore Impression Material (K251926) | Encore Guards | 2026-03-17 |
| Remi Impression Material (K251724) | Grindguard, Inc. | 2026-02-25 |
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