FDA product code ELM: Denture, Plastic, Teeth
ELM is the FDA product code for denture, plastic, teeth. It is a Class II device, regulated under 21 CFR 872.3590 and reviewed by the Dental panel. FDA has cleared 55 510(k) submissions under ELM, from 42 different applicants. The average 510(k) review took 106 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Denture, Plastic, Teeth |
| Device class | Class II |
| Regulation | 21 CFR 872.3590 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Top ELM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ivoclar Vivadent, Inc. | 4 | 2014-01-14 |
| Dentsply Intl. | 4 | 1992-12-23 |
| Heraeus Kulzer, Inc. | 3 | 2006-05-22 |
| Shofu Dental Corporation | 2 | 2012-09-07 |
| Merz Dental GmbH | 2 | 2012-05-21 |
37 more applicants have ELM clearances. See the full list in Caduvo.
Most recent ELM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132984 | Ivoclar Vivadent, Inc. | SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S | 2014-01-14 | 112 |
| K122955 | Wright Health Group , Ltd. | DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM | 2013-03-01 | 157 |
| K122925 | New Stetic | NEW STETIC ARTIFICIAL TEETH | 2013-02-12 | 141 |
| K122852 | Candulor USA, Inc. | PHYSIOSTAR NFC | 2012-12-06 | 79 |
| K121749 | Shofu Dental Corporation | VERACIA | 2012-09-07 | 85 |
Recalls for ELM devices
openFDA lists no recalls for product code ELM.
Frequently asked questions
What is FDA product code ELM?
ELM is the FDA product code for denture, plastic, teeth. It is a Class II device, regulated under 21 CFR 872.3590 and reviewed by the Dental panel.
What device class is ELM?
Class II, regulation 21 CFR 872.3590. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ELM?
Across 55 cleared submissions the average was 106 days from receipt to decision (median 80).
Which companies have the most ELM clearances?
Ivoclar Vivadent, Inc. (4); Dentsply Intl. (4); Heraeus Kulzer, Inc. (3); Shofu Dental Corporation (2); Merz Dental GmbH (2).
Next steps
- Run an FDA pathway report with predicate devices for product code ELM
- Run a recall and safety report across every ELM manufacturer
- Watch product code ELM 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.