Product code EMB
- Device name
- Zinc Oxide Eugenol
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.3275
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K161630 | Provicol QM Plus | Voco GmbH | 2016-09-15 |
| K120695 | DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT | Dentist IN A Box Pty., Ltd. | 2012-06-12 |
| K110759 | TEMPOCEM | Dmg USA, Inc. | 2011-06-10 |
| K073539 | PROVISA CEM | Cavex Holland BV | 2008-01-31 |
| K020158 | NON-EUGENOL TEMPORARY CEMENT | J. Morita USA, Inc. | 2002-03-07 |
| K941066 | DENTAL 911 | L.A.F. Industries, Inc. | 1995-05-24 |
| K861681 | DENTIMEDIC DENTAL EMERGENCY KIT | Dentimedic | 1986-09-23 |
| K862745 | EUGENOL USP | E&D Dental Manufacturing Co. | 1986-07-31 |
| K821581 | DEN TEMP | Majestic Drug Co., Inc. | 1982-06-14 |
| K801779 | OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT | Oxy Dental Products, Inc. | 1980-08-07 |
| K772315 | KWIKAP | Den-Mat Corp. | 1978-01-03 |
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| D161280150 | AxioIRM 75g powder 40ml liquid | Axiodent Inc. | 2024-09-29 |
| D161280140 | AxioIRM 15g powder 10ml liquid | Axiodent Inc. | 2024-09-29 |
| 07898561542205 | Maquira | Maquira Industria de Produtos Odontologicos S/A | 2024-08-07 |
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| D8199002390 | 3-Part TS Herbst Kit | SPECIALTY APPLIANCES, LLC | 2022-11-21 |
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| 04035077001908 | RelyX™ Temp E | 3M Deutschland GmbH | 2017-08-04 |
| J001702011153370 | RelyX™ Temp E | 3M Deutschland GmbH | 2016-09-24 |
| D6870011804FG2 | Zinc Oxide U.S.P. | DENTSPLY INTERNATIONAL INC. | 2016-09-21 |
| D6870011803FG2 | Zinc Oxide U.S.P. | DENTSPLY INTERNATIONAL INC. | 2016-09-21 |
| 00010705400814 | DenTemp Custom | MAJESTIC DRUG CO. INC. | 2016-07-27 |
| D724D4407021 | VividLute Standard Package | PEARSON DENTAL SUPPLIES, INC. | 2016-06-30 |