FDA Product Code
FDA Product Code SHI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3660
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261888 | ClearClub Impression Material | ClearClub | 2026-09-16 | Traditional | PDF ↗ |
| K251926 | enCore Impression Material | Encore Guards | 2026-03-17 | Traditional | PDF ↗ |
| K251724 | Remi Impression Material | Grindguard, Inc. | 2026-02-25 | Traditional | PDF ↗ |
Product code SHI · Class II · Dental. Data: openFDA.