GLASS POST
FDA 510(k) clearance K012849 · decided 2002-03-27
Clearance details
- K-number
- K012849
- Device name
- GLASS POST
- Applicant
- J. Morita USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-03
- Decision date
- 2002-03-27
- Days to decision
- 236 days
- Clearance type
- Traditional
- Product code
- ELR
- Device class
- 1
- Regulation number
- 872.3810
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, 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 |
|---|---|---|
| FIBER-METAL POST (K060075) | Foremost Dental, LLC | 2006-03-30 |
| FRC POSTEC PLUS (K042848) | Ivoclar Vivadent, Inc. | 2004-11-22 |
| EVERSTICK POST (K030820) | Stick Tech , Ltd. | 2003-05-20 |
| FIBIOCORE (K020431) | Est. Anthogyr | 2002-07-03 |
| CARBON POST (K012496) | J. Morita USA, Inc. | 2002-05-17 |
| FRC POSTEC (K013802) | Ivoclar Vivadent, Inc. | 2002-05-01 |
| SNOWPOST, SNOWLIGHT (K012354) | Danville Materials, Inc. | 2001-10-10 |
| HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST (K003221) | Harald Nordin S.A | 2000-10-25 |
| HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST (K003219) | Harald Nordin S.A | 2000-10-25 |
| TENAX WHITE POST (K993545) | Coltene/Whaledent, Inc. | 2000-04-14 |
| PARAPOST FIBER WHITE (K000311) | Coltene/Whaledent, Inc. | 2000-03-14 |
| FIBREKOR POST SYSTEM (K983266) | Jeneric/Pentron, Inc. | 1998-11-09 |
Recalls involving this device
No recalls on record reference this clearance.