ECR
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Setter, Band, Orthodontic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BAND SEATER (K951776) | Ormco Corp. | 1995-05-23 |
| DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS (K935156) | Dentauraum, Inc. | 1994-02-03 |
| FLEXI-POST (K843018) | Essential Dental Systems, Inc. | 1984-09-27 |
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Every clearance here is in the API, with alerts when new ones post.