510(k) K870130
- Device
- DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM
- Applicant
- DEN-MAT CORP.
- 510(k) number
- K870130
- Product code
- ELR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-02-19
- Date received
- 1987-01-12
- Regulation
- 872.3810
- Classification name
- Post, Root Canal
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT L IBSEN
- Address
- P.O. Box 1729 Santa Maria CA US 93456 93456
FDA Registration Numbers#
- 3027344570
- 3038718579
- 3030648980
- 1415367
- 9611385
- 3032378317
- 3001226627
- 3006542438
- 2024980
- 8030870
- 8031054
- 2081055
- 3017910185
- 2511556
- 2023950
- 3012322979
- 2411797
- 3032911850
- 2416455
- 8010468
- 8010908
- 3015136927
- 1222993
- 1410097
- 3007210751
- 3003231822
- 2921595
- 8030938
- 3004130302
- 2918719
- 8044177
- 3009117991
- 2247044
- 2435118
- 8044164
- 1836161
- 3043226252
- 3030015903
- 3012477813
- 3035693034
- 3012421607
- 9680939
- 3018159969
- 2086043
- 3006405073
- 3003418325
- 8010414
- 1718912
- 8031058
- 3013557562
- 3022516928
- 2024312
- 3008757014
- 3013557697
- 3005216725
- 2433629
- 3006697692
- 3023852420
- 1525838
- 3003600526
- 3021023132
- 9710611
- 1032227
- 3001644167
- 3018662547
- 3009171220
- 3016170492
- 2018957
- 3014334038
- 1044031
- 3005831677
- 3012187973
- 3043648115
- 3010864832
- 3013538161
- 3009850967
- 8031010
- 3011554142
- 3007597023
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ELR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060075 | FIBER-METAL POST | Foremost Dental, LLC | 2006-03-30 |
| K042848 | FRC POSTEC PLUS | Ivoclar Vivadent, Inc. | 2004-11-22 |
| K030820 | EVERSTICK POST | Stick Tech , Ltd. | 2003-05-20 |
| K020431 | FIBIOCORE | Est. Anthogyr | 2002-07-03 |
| K012496 | CARBON POST | J. Morita USA, Inc. | 2002-05-17 |
| K013802 | FRC POSTEC | Ivoclar Vivadent, Inc. | 2002-05-01 |
| K012849 | GLASS POST | J. Morita USA, Inc. | 2002-03-27 |
| K012354 | SNOWPOST, SNOWLIGHT | Danville Materials, Inc. | 2001-10-10 |
| K003219 | HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST | Harald Nordin S.A | 2000-10-25 |
| K003221 | HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST | Harald Nordin S.A | 2000-10-25 |
| K993545 | TENAX WHITE POST | Coltene/Whaledent, Inc. | 2000-04-14 |
| K000311 | PARAPOST FIBER WHITE | Coltene/Whaledent, Inc. | 2000-03-14 |
| K983266 | FIBREKOR POST SYSTEM | Jeneric/Pentron, Inc. | 1998-11-09 |
| K983161 | KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC | Sabre-K , Ltd. | 1998-09-30 |
| K974649 | BIO-POST DENTAL POST SYSTEM | Advanced Aeromedical, Inc. | 1998-05-01 |
Legacy Summary#
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FDA Review#
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