EKQ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Preparer, Root Canal Endodontic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1994: 1
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 |
|---|---|---|
| VIBRATORY ENDODONTIC SYSTEM (K832378) | Syntex Dental Products, Inc. | 1983-10-04 |
| OJ-1 ENDODONIC ROOT CANAL FILE HOLDER (K801463) | Almore Intl., Inc. | 1980-07-21 |
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Every clearance here is in the API, with alerts when new ones post.