FDA product code EFA: Handpiece, Belt And/Or Gear Driven, Dental
EFA is the FDA product code for handpiece, belt and/or gear driven, dental. It is a Class I device, regulated under 21 CFR 872.4200 and reviewed by the Dental panel. FDA has cleared 25 510(k) submissions under EFA, from 18 different applicants. The average 510(k) review took 92 days (median 70). FDA has posted 3 recalls for EFA devices.
Classification
| Field | Value |
|---|---|
| Device name | Handpiece, Belt And/Or Gear Driven, Dental |
| Device class | Class I |
| Regulation | 21 CFR 872.4200 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EFA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 119 |
| 2020 | 1 | 329 |
Compare with all 510(k) review times · Search every EFA clearance
Top EFA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Anthogyr | 3 | 2010-03-03 |
| Dentalez Group | 3 | 1996-03-28 |
| Kaltenbach & Voigt GmbH | 2 | 2017-03-17 |
| J. Morita USA, Inc. | 2 | 2006-08-25 |
| Dentsply Intl. | 2 | 1997-06-04 |
13 more applicants have EFA clearances. See the full list in Caduvo.
Most recent EFA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192809 | Micro-Nx Co., Ltd. | Dental Handpiece | 2020-08-25 | 329 |
| K163239 | Kaltenbach & Voigt GmbH | SMARTmatic | 2017-03-17 | 119 |
| K143465 | Kaltenbach & Voigt GmbH | MASTERmatic LUX | 2015-04-09 | 126 |
| K101172 | Redent Nova, Ltd. | RDT3 HANDPIECE HEAD MODEL RDT3 | 2010-07-27 | 92 |
| K093894 | Anthogyr | ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE | 2010-03-03 | 75 |
Recalls for EFA devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-06-13.
Frequently asked questions
What is FDA product code EFA?
EFA is the FDA product code for handpiece, belt and/or gear driven, dental. It is a Class I device, regulated under 21 CFR 872.4200 and reviewed by the Dental panel.
What device class is EFA?
Class I, regulation 21 CFR 872.4200. Typical premarket route: 510(k).
How long does a 510(k) take for product code EFA?
Across 25 cleared submissions the average was 92 days from receipt to decision (median 70).
Which companies have the most EFA clearances?
Anthogyr (3); Dentalez Group (3); Kaltenbach & Voigt GmbH (2); J. Morita USA, Inc. (2); Dentsply Intl. (2).
Have EFA devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2014-06-13.
Next steps
- Run an FDA pathway report with predicate devices for product code EFA
- Run a recall and safety report across every EFA manufacturer
- Watch product code EFA 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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