DEN TEMP
FDA 510(k) clearance K821581 · decided 1982-06-14
Clearance details
- K-number
- K821581
- Device name
- DEN TEMP
- Applicant
- Majestic Drug Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-05-28
- Decision date
- 1982-06-14
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- EMB
- Device class
- 1
- Regulation number
- 872.3275
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT (K801779) | Oxy Dental Products, Inc. | 1980-08-07 |
| KWIKAP (K772315) | Den-Mat Corp. | 1978-01-03 |
Recalls involving this device
No recalls on record reference this clearance.