FDA product code EMB: Zinc Oxide Eugenol
EMB is the FDA product code for zinc oxide eugenol. It is a Class I device, regulated under 21 CFR 872.3275 and reviewed by the Dental panel. FDA has cleared 11 510(k) submissions under EMB, from 11 different applicants. The average 510(k) review took 92 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Zinc Oxide Eugenol |
| Device class | Class I |
| Regulation | 21 CFR 872.3275 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EMB clearance
Top EMB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Voco GmbH | 1 | 2016-09-15 |
| Dentist IN A Box Pty., Ltd. | 1 | 2012-06-12 |
| Dmg USA, Inc. | 1 | 2011-06-10 |
| Cavex Holland BV | 1 | 2008-01-31 |
| J. Morita USA, Inc. | 1 | 2002-03-07 |
6 more applicants have EMB clearances. See the full list in Caduvo.
Most recent EMB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161630 | Voco GmbH | Provicol QM Plus | 2016-09-15 | 94 |
| K120695 | Dentist IN A Box Pty., Ltd. | DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT | 2012-06-12 | 97 |
| K110759 | Dmg USA, Inc. | TEMPOCEM | 2011-06-10 | 84 |
| K073539 | Cavex Holland BV | PROVISA CEM | 2008-01-31 | 45 |
| K020158 | J. Morita USA, Inc. | NON-EUGENOL TEMPORARY CEMENT | 2002-03-07 | 49 |
Recalls for EMB devices
openFDA lists no recalls for product code EMB.
Frequently asked questions
What is FDA product code EMB?
EMB is the FDA product code for zinc oxide eugenol. It is a Class I device, regulated under 21 CFR 872.3275 and reviewed by the Dental panel.
What device class is EMB?
Class I, regulation 21 CFR 872.3275. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EMB?
Across 11 cleared submissions the average was 92 days from receipt to decision (median 49).
Which companies have the most EMB clearances?
Voco GmbH (1); Dentist IN A Box Pty., Ltd. (1); Dmg USA, Inc. (1); Cavex Holland BV (1); J. Morita USA, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EMB
- Run a recall and safety report across every EMB manufacturer
- Watch product code EMB 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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