ELS
6 FDA 510(k) clearances · Product code
85 daysmedian time to decision
631 days90th percentile
6clearances measured
FDA profile
- Official device name
- Splint, Endodontic Stabilizing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3890
- Medical specialty
- Dental
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SPLINT IT (K972985) | Jeneric/Pentron, Inc. | 1997-09-24 |
| MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM (K961704) | Dentatus USA , Ltd. | 1996-07-26 |
| FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING (K922673) | Glasspan, Inc. | 1994-02-25 |
| ENDIX RADICULAR BIOCERAMIC PIN (K834363) | C.B.S. Biotechnics, Inc. | 1984-02-27 |
| JACOB WIRZ TRANSFIXATION PIN (K811209) | Colmed, Ltd. | 1981-06-16 |
| ZEST ENDODONTIC STABILIZER (K801525) | Zest Anchors, Inc. | 1980-07-21 |
Track ELS automatically
Every clearance here is in the API, with alerts when new ones post.