CERAM-ETCH
FDA 510(k) clearance K854494 · decided 1985-12-23
Clearance details
- K-number
- K854494
- Device name
- CERAM-ETCH
- Applicant
- Gresco Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-12
- Decision date
- 1985-12-23
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- EBC
- Device class
- 2
- Regulation number
- 872.3765
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Stafford, TX, US
- Third-party review
- No
- Expedited review
- No
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| Helioseal F Plus (K190339) | Ivoclar Vivadent, AG | 2019-07-29 |
| Pulpdent (Activa) Pit and Fissure Sealant with MCP (K172169) | Pulpdent Corporation | 2018-01-05 |
| Nanova Sealant (K171330) | Nanova Biomaterials, Inc. | 2017-09-08 |
| HAPI Seal (K162598) | Bisco, Inc. | 2017-05-23 |
| Premier Sealant (K161580) | Premier Dental Company Products | 2016-10-18 |
| PACSEAL PIT & FISSURE SEALANT (K141717) | Pac-Dent International, Inc. | 2015-03-09 |
| CONTROL SEAL (K130485) | Voco GmbH | 2014-02-11 |
Recalls involving this device
No recalls on record reference this clearance.