EMB · Zinc Oxide Eugenol
Dental · 21 CFR 872.3275 · Class 1
Overview
| Product Code | EMB |
|---|---|
| Device Name | Zinc Oxide Eugenol |
| Regulation | 21 CFR 872.3275 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.
Classification Rationale
Zinc oxide-eugenol: Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. Dental cement other than zinc oxide-eugenol: Class II.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K161630 | Provicol QM Plus | Voco GmbH | Sep 15, 2016 | SESE |
| K120695 | DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT | Dentist IN A Box Pty., Ltd. | Jun 12, 2012 | SESE |
| K110759 | TEMPOCEM | Dmg USA, Inc. | Jun 10, 2011 | SESE |
| K073539 | PROVISA CEM | Cavex Holland BV | Jan 31, 2008 | SESE |
| K020158 | NON-EUGENOL TEMPORARY CEMENT | J. Morita USA, Inc. | Mar 7, 2002 | SESE |
| K941066 | DENTAL 911 | L.A.F. Industries, Inc. | May 24, 1995 | SESE |
| K861681 | DENTIMEDIC DENTAL EMERGENCY KIT | Dentimedic | Sep 23, 1986 | SESE |
| K862745 | EUGENOL USP | E&D Dental Manufacturing Co. | Jul 31, 1986 | SESE |
| K821581 | DEN TEMP | Majestic Drug Co., Inc. | Jun 14, 1982 | SESE |
| K801779 | OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT | Oxy Dental Products, Inc. | Aug 7, 1980 | SESE |
| K772315 | KWIKAP | Den-Mat Corp. | Jan 3, 1978 | SESE |
Top Applicants
- Voco GmbH — 1 clearance
- Oxy Dental Products, Inc. — 1 clearance
- Majestic Drug Co., Inc. — 1 clearance
- L.A.F. Industries, Inc. — 1 clearance
- J. Morita USA, Inc. — 1 clearance
