ECQ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Aligner, Bracket, Orthodontic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1997: 1 · 1998: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DENTAURUM BRACKET POSITIONING GAUGE (K935153) | Dentauraum, Inc. | 1994-01-31 |
| A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS (K851454) | A Company, Inc. | 1985-04-29 |
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Every clearance here is in the API, with alerts when new ones post.