Prosthetic devices · 21 CFR 872 Subpart D
Endodontic Stabilizing Splint
FDA device type “Splint, Endodontic Stabilizing”.
- Companies listing it
- 44 makers
- Brands and models
- 4
- 510(k) clearances
- 60 in five years
- FDA name
- Splint, Endodontic Stabilizing
510(k) clearances per year, 1976–2026
Companies that list ELS
4 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Practicon, Inc. | United States | Maker | GlasSpan Dental Fiber | — | — |
| one day dental partner | South Korea | Maker | kage splint | — | — |
| INKA Surgical Instruments | Australia | Maker | N/A | — | — |
| Dentrade GmbH & Co.KG | Germany | Maker | RehaSplint | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 24 Sep 1997 | K972985 | SPLINT IT | Jeneric/Pentron, Inc. |
| 26 Jul 1996 | K961704 | MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM | Dentatus USA Ltd. |
| 25 Feb 1994 | K922673 | FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING | Glasspan, Inc. |
| 27 Feb 1984 | K834363 | ENDIX RADICULAR BIOCERAMIC PIN | C.B.S. Biotechnics, Inc. |
| 16 Jun 1981 | K811209 | JACOB WIRZ TRANSFIXATION PIN | Colmed, Ltd. |
| 21 Jul 1980 | K801525 | ZEST ENDODONTIC STABILIZER | Zest Anchors, LLC |
Official records: FDA product classification for ELS · 21 CFR 872.3890.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026