Zinc Oxide Eugenol
Zinc Oxide Eugenol (ZOE) is a dental material composed of zinc oxide powder and eugenol liquid that, when mixed, forms a paste used as a temporary cement, sedative base, pulp capping agent, or impression material due to its obtundent and antimicrobial properties. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EMB, regulated under 21 CFR 872.3275 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EMB
- Device Class
- FDA class 1
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K161630 | Provicol QM Plus | Sep 15, 2016 | Substantially Equivalent | Voco GmbH |
| K120695 | DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT | Jun 12, 2012 | Substantially Equivalent | Dentist IN A Box Pty., Ltd. |
| K110759 | TEMPOCEM | Jun 10, 2011 | Substantially Equivalent | Dmg USA, Inc. |
| K073539 | PROVISA CEM | Jan 31, 2008 | Substantially Equivalent | Cavex Holland BV |
| K020158 | NON-EUGENOL TEMPORARY CEMENT | Mar 07, 2002 | Substantially Equivalent | J. Morita USA, Inc. |
| K941066 | DENTAL 911 | May 24, 1995 | Substantially Equivalent | L.A.F. Industries, Inc. |
| K861681 | DENTIMEDIC DENTAL EMERGENCY KIT | Sep 23, 1986 | Substantially Equivalent | Dentimedic |
| K862745 | EUGENOL USP | Jul 31, 1986 | Substantially Equivalent | E&D Dental Manufacturing Co. |
| K821581 | DEN TEMP | Jun 14, 1982 | Substantially Equivalent | Majestic Drug Co., Inc. |
| K801779 | OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT | Aug 07, 1980 | Substantially Equivalent | Oxy Dental Products, Inc. |
| K772315 | KWIKAP | Jan 03, 1978 | Substantially Equivalent | Den-Mat Corp. |
FEI Numbers
This FDA classification entry is associated with 71 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 71 registration numbers. Click on an entry to view related FDA registrations.