EMB — Zinc Oxide Eugenol Class I
FDA product code EMB covers "Zinc Oxide Eugenol", a Class I medical device regulated under 21 CFR 872.3275. Submissions are reviewed by the Dental panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EMB
- Device Class
- Class I
- Regulation Number
- 872.3275
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K161630 | voco | Provicol QM Plus | September 15, 2016 |
| K120695 | dentist in a box pty | DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT | June 12, 2012 |
| K110759 | dmg usa | TEMPOCEM | June 10, 2011 |
| K073539 | cavex holland | PROVISA CEM | January 31, 2008 |
| K020158 | j. morita usa | NON-EUGENOL TEMPORARY CEMENT | March 7, 2002 |
| K941066 | l.a.f. industries | DENTAL 911 | May 24, 1995 |
| K861681 | dentimedic | DENTIMEDIC DENTAL EMERGENCY KIT | September 23, 1986 |
| K862745 | e and d dental manufacturing | EUGENOL USP | July 31, 1986 |
| K821581 | majestic drug co | DEN TEMP | June 14, 1982 |
| K801779 | oxy dental products | OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT | August 7, 1980 |
| K772315 | den-mat | KWIKAP | January 3, 1978 |