FDA product code EFD: Amalgamator, Dental, Ac-Powered
EFD is the FDA product code for amalgamator, dental, ac-powered. It is a Class I device, regulated under 21 CFR 872.3100 and reviewed by the Dental panel. FDA has cleared 15 510(k) submissions under EFD, from 12 different applicants. The average 510(k) review took 50 days (median 49). FDA has posted 1 recall for EFD devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Amalgamator, Dental, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 872.3100 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EFD clearance
Top EFD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Degussa AG | 3 | 1991-11-13 |
| Ivoclar North America, Inc. | 2 | 1992-10-06 |
| Espe Dental AG | 1 | 1999-07-26 |
| Ipt Technologies, Inc. | 1 | 1992-06-03 |
| Kerr Corporation (Danbury) | 1 | 1992-03-02 |
7 more applicants have EFD clearances. See the full list in Caduvo.
Most recent EFD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K991913 | Espe Dental AG | PENTAMIX 2 | 1999-07-26 | 49 |
| K923974 | Ivoclar North America, Inc. | SILIMAT PLUS | 1992-10-06 | 60 |
| K922203 | Ipt Technologies, Inc. | IPT CAPSULE MIXER | 1992-06-03 | 23 |
| K915847 | Kerr Corporation (Danbury) | AUTOMIX DENTAL AMALGAMATOR | 1992-03-02 | 67 |
| K914340 | Degussa AG | DUOMAT 3 AMALGAMATOR | 1991-11-13 | 47 |
Recalls for EFD devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-07-20.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code EFD?
EFD is the FDA product code for amalgamator, dental, ac-powered. It is a Class I device, regulated under 21 CFR 872.3100 and reviewed by the Dental panel.
What device class is EFD?
Class I, regulation 21 CFR 872.3100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EFD?
Across 15 cleared submissions the average was 50 days from receipt to decision (median 49).
Which companies have the most EFD clearances?
Degussa AG (3); Ivoclar North America, Inc. (2); Espe Dental AG (1); Ipt Technologies, Inc. (1); Kerr Corporation (Danbury) (1).
Have EFD devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-07-20.
Next steps
- Run an FDA pathway report with predicate devices for product code EFD
- Run a recall and safety report across every EFD manufacturer
- Watch product code EFD 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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