Post, Root Canal
FDA product code ELR · Class I (low risk) · 21 CFR 872.3810 · Dental
35510(k) clearances
0PMA approvals
2recalls
Manufacturers
- J. Morita USA, Inc. 3
- Coltene/Whaledent, Inc. 3
- Harald Nordin S.A 3
- Ivoclar Vivadent, Inc. 2
- Ivoclar North America, Inc. 2
- Veillette Ent. 1
- Foremost Dental, LLC 1
- Bisco, Inc. 1
- Sterngold/Implamed 1
- Dental Logics, Inc. 1
- Bull Frog Mfg. Co. 1
- Tulsa Dental Products, Ltd. 1
- Dental Power, Inc. 1
- Unitek Corp. 1
- Precident Corp. 1
- Metalor Dental USA Corp. 1
- Essential Dental Systems, Inc. 1
- Centrix, Inc. 1
- Den-Mat Corp. 1
- Arcee Dental Products Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K060075 | Fiber-Metal PostELR · Traditional | Foremost Dental, LLC | 03/30/2006SE |
| K042848 | FRC Postec PlusELR · Traditional | Ivoclar Vivadent, Inc. | 11/22/2004SE |
| K030820 | Everstick PostELR · Traditional | Stick Tech , Ltd. | 05/20/2003SE |
| K020431 | FibiocoreELR · Traditional | Est. Anthogyr | 07/03/2002SE |
| K012496 | Carbon PostELR · Traditional | J. Morita USA, Inc. | 05/17/2002SE |
| K013802 | FRC PostecELR · Traditional | Ivoclar Vivadent, Inc. | 05/01/2002SE |
| K012849 | Glass PostELR · Traditional | J. Morita USA, Inc. | 03/27/2002SE |
| K012354 | Snowpost, SnowlightELR · Traditional | Danville Materials, Inc. | 10/10/2001SE |
| K003221 | Harald Nordin Glassix Glass Fiber Composite Dental PostELR · Special | Harald Nordin S.A | 10/25/2000SE |
| K003219 | Harald Nordin Carbonite Carbon Fiber Composite Dental PostELR · Special | Harald Nordin S.A | 10/25/2000SE |
| K993545 | Tenax White PostELR · Traditional | Coltene/Whaledent, Inc. | 04/14/2000SE |
| K000311 | Parapost Fiber WhiteELR · Traditional | Coltene/Whaledent, Inc. | 03/14/2000SE |
| K983266 | Fibrekor Post SystemELR · Traditional | Jeneric/Pentron, Inc. | 11/09/1998SE |
| K983161 | Kurer Crown Saver K4 Anchor System-The Universal Kit, Kurer Standard K4 Anchor System-…ELR · Traditional | Sabre-K , Ltd. | 09/30/1998SE |
| K974649 | Bio-Post Dental Post SystemELR · Traditional | Advanced Aeromedical, Inc. | 05/01/1998SE |
| K972875 | CosmopostELR · Traditional | Ivoclar North America, Inc. | 09/17/1997SE |
| K945370 | C-PostELR · Traditional | Bisco, Inc. | 03/31/1995SE |
| K950213 | The Stern Root Anchor SystemELR · Traditional | Sterngold/Implamed | 03/23/1995SE |
| K942528 | IntegrapostELR · Traditional | Dental Logics, Inc. | 08/05/1994SE |
| K942521 | Conserva Post SystemELR · Traditional | Bull Frog Mfg. Co. | 07/08/1994SE |
| K934192 | Parapost XT SystemELR · Traditional | Coltene/Whaledent, Inc. | 06/06/1994SE |
| K922931 | Thermapost Endodontic Root Canal PostELR · Traditional | Tulsa Dental Products, Ltd. | 05/26/1994SE |
| K931396 | Dental Screw PostsELR · Traditional | Harald Nordin S.A | 04/28/1994SE |
| K940680 | Versadowel Post SystemELR · Traditional | Dental Power, Inc. | 03/15/1994SE |
| K923232 | Endodontic Post W/ AccessoriesELR · Traditional | Veillette Ent. | 03/05/1993SE |
| K913019 | Pdi Parallel Sided Post KitELR · Traditional | Precident Corp. | 10/02/1991SE |
| K912720 | Endo-CoreELR · Traditional | Metalor Dental USA Corp. | 08/20/1991SE |
| K896928 | FilpostELR · Traditional | Ivoclar North America, Inc. | 03/05/1990SE |
| K896693 | Flexi-Cast Crown Core SystemELR · Traditional | Essential Dental Systems, Inc. | 02/14/1990SE |
| K884277 | Ad PostELR · Traditional | J. Morita USA, Inc. | 12/22/1988SE |
| K882125 | Centrix Tri-Laminate Post SystemELR · Traditional | Centrix, Inc. | 08/11/1988SE |
| K870130 | Den-Mat Secure Anti-Rotational Post-Core SystemELR · Traditional | Den-Mat Corp. | 02/19/1987SE |
| K851038 | Arcee Dental PostELR · Traditional | Arcee Dental Products Co. | 04/29/1985SE |
| K812092 | Beta PostELR · Traditional | Paul B. Heller, D.M.D. | 08/20/1981SE |
| K802515 | Root Canal PostELR · Traditional | Unitek Corp. | 11/12/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0376-2019 Class II | ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B…ParaPost Plus Titanium Posts contain stainless steel post that are a size 4 | Coltene Whaledent Inc | 08/21/2018Terminated |
| Z-1234-2009 | Dentsply, MAILLEFER, CYTCO-K TITANIUM POST SYSTEM, dental implant components, Model…The product is manufactured with a left-hand thread instead of a right hand thread. This error could cause… | Dentsply Worldwide Headqrt | 03/20/2009Terminated |