EMB
11 FDA 510(k) clearances · Product code
49 daysmedian time to decision
145 days90th percentile
11clearances measured
FDA profile
- Official device name
- Zinc Oxide Eugenol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3275
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1994: 1 · 1999: 1 · 2001: 3 · 2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Provicol QM Plus (K161630) | Voco GmbH | 2016-09-15 |
| DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT (K120695) | Dentist IN A Box Pty., Ltd. | 2012-06-12 |
| TEMPOCEM (K110759) | Dmg USA, Inc. | 2011-06-10 |
| PROVISA CEM (K073539) | Cavex Holland BV | 2008-01-31 |
| NON-EUGENOL TEMPORARY CEMENT (K020158) | J. Morita USA, Inc. | 2002-03-07 |
| DENTAL 911 (K941066) | L.A.F. Industries, Inc. | 1995-05-24 |
| DENTIMEDIC DENTAL EMERGENCY KIT (K861681) | Dentimedic | 1986-09-23 |
| EUGENOL USP (K862745) | E&D Dental Manufacturing Co. | 1986-07-31 |
| DEN TEMP (K821581) | Majestic Drug Co., Inc. | 1982-06-14 |
| OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT (K801779) | Oxy Dental Products, Inc. | 1980-08-07 |
| KWIKAP (K772315) | Den-Mat Corp. | 1978-01-03 |
Track EMB automatically
Every clearance here is in the API, with alerts when new ones post.