FDA product code ELR: Post, Root Canal
ELR is the FDA product code for post, root canal. It is a Class I device, regulated under 21 CFR 872.3810 and reviewed by the Dental panel. FDA has cleared 35 510(k) submissions under ELR, from 27 different applicants. The average 510(k) review took 120 days (median 71). FDA has posted 2 recalls for ELR devices.
Classification
| Field | Value |
|---|---|
| Device name | Post, Root Canal |
| Device class | Class I |
| Regulation | 21 CFR 872.3810 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every ELR clearance
Top ELR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J. Morita USA, Inc. | 3 | 2002-05-17 |
| Harald Nordin S.A | 3 | 2000-10-25 |
| Coltene/Whaledent, Inc. | 3 | 2000-04-14 |
| Ivoclar Vivadent, Inc. | 2 | 2004-11-22 |
| Ivoclar North America, Inc. | 2 | 1997-09-17 |
22 more applicants have ELR clearances. See the full list in Caduvo.
Most recent ELR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060075 | Foremost Dental, LLC | FIBER-METAL POST | 2006-03-30 | 79 |
| K042848 | Ivoclar Vivadent, Inc. | FRC POSTEC PLUS | 2004-11-22 | 38 |
| K030820 | Stick Tech , Ltd. | EVERSTICK POST | 2003-05-20 | 67 |
| K020431 | Est. Anthogyr | FIBIOCORE | 2002-07-03 | 145 |
| K012496 | J. Morita USA, Inc. | CARBON POST | 2002-05-17 | 287 |
Recalls for ELR devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-08-21.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code ELR?
ELR is the FDA product code for post, root canal. It is a Class I device, regulated under 21 CFR 872.3810 and reviewed by the Dental panel.
What device class is ELR?
Class I, regulation 21 CFR 872.3810. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ELR?
Across 35 cleared submissions the average was 120 days from receipt to decision (median 71).
Which companies have the most ELR clearances?
J. Morita USA, Inc. (3); Harald Nordin S.A (3); Coltene/Whaledent, Inc. (3); Ivoclar Vivadent, Inc. (2); Ivoclar North America, Inc. (2).
Have ELR devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2018-08-21.
Next steps
- Run an FDA pathway report with predicate devices for product code ELR
- Run a recall and safety report across every ELR manufacturer
- Watch product code ELR 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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