ELS — Splint, Endodontic Stabilizing Class II
FDA product code ELS covers "Splint, Endodontic Stabilizing", a Class II medical device regulated under 21 CFR 872.3890. Submissions are reviewed by the Dental panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ELS
- Device Class
- Class II
- Regulation Number
- 872.3890
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K972985 | jeneric/pentron | SPLINT IT | September 24, 1997 |
| K961704 | dentatus usa | MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM | July 26, 1996 |
| K922673 | glasspan | FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING | February 25, 1994 |
| K834363 | c.b.s. biotechnics | ENDIX RADICULAR BIOCERAMIC PIN | February 27, 1984 |
| K811209 | colmed | JACOB WIRZ TRANSFIXATION PIN | June 16, 1981 |
| K801525 | zest anchors | ZEST ENDODONTIC STABILIZER | July 21, 1980 |