TEMPOCEM
FDA 510(k) clearance K110759 · decided 2011-06-10
Clearance details
- K-number
- K110759
- Device name
- TEMPOCEM
- Applicant
- Dmg USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-18
- Decision date
- 2011-06-10
- Days to decision
- 84 days
- Clearance type
- Abbreviated
- Product code
- EMB
- Device class
- 1
- Regulation number
- 872.3275
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Ayer, MA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Provicol QM Plus (K161630) | Voco GmbH | 2016-09-15 |
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| 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 |
Recalls involving this device
No recalls on record reference this clearance.