ELR · Post, Root Canal
Dental · 21 CFR 872.3810 · Class 1
Overview
| Product Code | ELR |
|---|---|
| Device Name | Post, Root Canal |
| Regulation | 21 CFR 872.3810 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (20 of 35)
Showing 20 most recent of 35 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K060075 | FIBER-METAL POST | Foremost Dental, LLC | Mar 30, 2006 | SESE |
| K042848 | FRC POSTEC PLUS | Ivoclar Vivadent, Inc. | Nov 22, 2004 | SESE |
| K030820 | EVERSTICK POST | Stick Tech , Ltd. | May 20, 2003 | SESE |
| K020431 | FIBIOCORE | Est. Anthogyr | Jul 3, 2002 | SESE |
| K012496 | CARBON POST | J. Morita USA, Inc. | May 17, 2002 | SESE |
| K013802 | FRC POSTEC | Ivoclar Vivadent, Inc. | May 1, 2002 | SESE |
| K012849 | GLASS POST | J. Morita USA, Inc. | Mar 27, 2002 | SESE |
| K012354 | SNOWPOST, SNOWLIGHT | Danville Materials, Inc. | Oct 10, 2001 | SESE |
| K003221 | HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST | Harald Nordin S.A | Oct 25, 2000 | SESE |
| K003219 | HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST | Harald Nordin S.A | Oct 25, 2000 | SESE |
| K993545 | TENAX WHITE POST | Coltene/Whaledent, Inc. | Apr 14, 2000 | SESE |
| K000311 | PARAPOST FIBER WHITE | Coltene/Whaledent, Inc. | Mar 14, 2000 | SESE |
| K983266 | FIBREKOR POST SYSTEM | Jeneric/Pentron, Inc. | Nov 9, 1998 | SESE |
| 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. | Sep 30, 1998 | SESE |
| K974649 | BIO-POST DENTAL POST SYSTEM | Advanced Aeromedical, Inc. | May 1, 1998 | SESE |
| K972875 | COSMOPOST | Ivoclar North America, Inc. | Sep 17, 1997 | SESE |
| K945370 | C-POST | Bisco, Inc. | Mar 31, 1995 | SESE |
| K950213 | THE STERN ROOT ANCHOR SYSTEM | Sterngold/Implamed | Mar 23, 1995 | SESE |
| K942528 | INTEGRAPOST | Dental Logics, Inc. | Aug 5, 1994 | SESE |
| K942521 | CONSERVA POST SYSTEM | Bull Frog Mfg. Co. | Jul 8, 1994 | SESE |
Top Applicants
- Coltene/Whaledent, Inc. — 3 clearances
- Harald Nordin S.A — 3 clearances
- J. Morita USA, Inc. — 3 clearances
- Ivoclar North America, Inc. — 2 clearances
- Ivoclar Vivadent, Inc. — 2 clearances
