ELK
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Teeth, Artificial, Backing And Facing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3910
- Medical specialty
- Dental
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SR-ISOCETTE (K811665) | J. Aderer, Inc. | 1981-07-15 |
| THERMOMETER JARS AND CAPS (K760909) | Plastics/Packaging | 1976-12-30 |
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Every clearance here is in the API, with alerts when new ones post.