FDA product code ELS: Splint, Endodontic Stabilizing
ELS is the FDA product code for splint, endodontic stabilizing. It is a Class II device, regulated under 21 CFR 872.3890 and reviewed by the Dental panel. FDA has cleared 6 510(k) submissions under ELS, from 6 different applicants. The average 510(k) review took 158 days (median 66).
Classification
| Field | Value |
|---|---|
| Device name | Splint, Endodontic Stabilizing |
| Device class | Class II |
| Regulation | 21 CFR 872.3890 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every ELS clearance
Top ELS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jeneric/Pentron, Inc. | 1 | 1997-09-24 |
| Dentatus USA , Ltd. | 1 | 1996-07-26 |
| Glasspan, Inc. | 1 | 1994-02-25 |
| C.B.S. Biotechnics, Inc. | 1 | 1984-02-27 |
| Colmed, Ltd. | 1 | 1981-06-16 |
1 more applicants have ELS clearances. See the full list in Caduvo.
Most recent ELS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972985 | Jeneric/Pentron, Inc. | SPLINT IT | 1997-09-24 | 44 |
| K961704 | Dentatus USA , Ltd. | MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM | 1996-07-26 | 85 |
| K922673 | Glasspan, Inc. | FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING | 1994-02-25 | 631 |
| K834363 | C.B.S. Biotechnics, Inc. | ENDIX RADICULAR BIOCERAMIC PIN | 1984-02-27 | 123 |
| K811209 | Colmed, Ltd. | JACOB WIRZ TRANSFIXATION PIN | 1981-06-16 | 46 |
Recalls for ELS devices
openFDA lists no recalls for product code ELS.
Frequently asked questions
What is FDA product code ELS?
ELS is the FDA product code for splint, endodontic stabilizing. It is a Class II device, regulated under 21 CFR 872.3890 and reviewed by the Dental panel.
What device class is ELS?
Class II, regulation 21 CFR 872.3890. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ELS?
Across 6 cleared submissions the average was 158 days from receipt to decision (median 66).
Which companies have the most ELS clearances?
Jeneric/Pentron, Inc. (1); Dentatus USA , Ltd. (1); Glasspan, Inc. (1); C.B.S. Biotechnics, Inc. (1); Colmed, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ELS
- Run a recall and safety report across every ELS manufacturer
- Watch product code ELS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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