ECM
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Band, Preformed, Orthodontic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.5410
- Medical specialty
- Dental
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MICODOSE CHLORHEXIPREP (K925163) | Unicep | 1993-05-27 |
| TITANE SL DENTAL BURR (K872471) | Titane SL Co. | 1987-09-11 |
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Every clearance here is in the API, with alerts when new ones post.