Product Code: ELR
FDA class 1
21 CFR 872.3810
Post, Root Canal
Dental
The Root Canal Post is a dental component inserted and cemented into the prepared root canal space following endodontic treatment, providing structural retention for a core build-up and overlying crown in teeth with insufficient coronal tooth structure. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is ELR, regulated under 21 CFR 872.3810 in the Dental (DE) specialty.
510(k)s
35
FEI Numbers
93
Registration Numbers
93
Unique Applicants
28
Years Active
25
Basic Information
- Product Code
- ELR
- Device Class
- FDA class 1
- Regulation Number
- 872.3810
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 35 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K060075 | FIBER-METAL POST | Mar 30, 2006 | Substantially Equivalent | FOREMOST DENTAL LLC. |
| K042848 | FRC POSTEC PLUS | Nov 22, 2004 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K030820 | EVERSTICK POST | May 20, 2003 | Substantially Equivalent | STICK TECH LTD. |
| K020431 | FIBIOCORE | Jul 03, 2002 | Substantially Equivalent | EST. ANTHOGYR |
| K012496 | CARBON POST | May 17, 2002 | Substantially Equivalent | J. MORITA USA, INC. |
| K013802 | FRC POSTEC | May 01, 2002 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K012849 | GLASS POST | Mar 27, 2002 | Substantially Equivalent | J. MORITA USA, INC. |
| K012354 | SNOWPOST, SNOWLIGHT | Oct 10, 2001 | Substantially Equivalent | DANVILLE MATERIALS, INC. |
| K003221 | HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST | Oct 25, 2000 | Substantially Equivalent | HARALD NORDIN S.A |
| K003219 | HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST | Oct 25, 2000 | Substantially Equivalent | HARALD NORDIN S.A |
| K993545 | TENAX WHITE POST | Apr 14, 2000 | Substantially Equivalent | COLTENE/WHALEDENT INC. |
| K000311 | PARAPOST FIBER WHITE | Mar 14, 2000 | Substantially Equivalent | COLTENE/WHALEDENT INC. |
| K983266 | FIBREKOR POST SYSTEM | Nov 09, 1998 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K983161 | KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC | Sep 30, 1998 | Substantially Equivalent | SABRE-K LTD. |
| K974649 | BIO-POST DENTAL POST SYSTEM | May 01, 1998 | Substantially Equivalent | ADVANCED AEROMEDICAL, INC. |
| K972875 | COSMOPOST | Sep 17, 1997 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K945370 | C-POST | Mar 31, 1995 | Substantially Equivalent | BISCO, INC. |
| K950213 | THE STERN ROOT ANCHOR SYSTEM | Mar 23, 1995 | Substantially Equivalent | STERNGOLD/IMPLAMED |
| K942528 | INTEGRAPOST | Aug 05, 1994 | Substantially Equivalent | DENTAL LOGICS, INC. |
| K942521 | CONSERVA POST SYSTEM | Jul 08, 1994 | Substantially Equivalent | BULL FROG MFG. CO. |
| K934192 | PARAPOST XT SYSTEM | Jun 06, 1994 | Substantially Equivalent | COLTENE/WHALEDENT INC. |
| K922931 | THERMAPOST ENDODONTIC ROOT CANAL POST | May 26, 1994 | Substantially Equivalent | TULSA DENTAL PRODUCTS, LTD. |
| K931396 | DENTAL SCREW POSTS | Apr 28, 1994 | Substantially Equivalent | HARALD NORDIN SA |
| K940680 | VERSADOWEL POST SYSTEM | Mar 15, 1994 | Substantially Equivalent | DENTAL POWER, INC. |
| K923232 | ENDODONTIC POST W/ ACCESSORIES | Mar 05, 1993 | Substantially Equivalent | VEILLETTE ENT. |
| K913019 | PDI PARALLEL SIDED POST KIT | Oct 02, 1991 | Substantially Equivalent | PRECI DENT CORP. |
| K912720 | ENDO-CORE | Aug 20, 1991 | Substantially Equivalent | METALOR DENTAL USA CORP. |
| K896928 | FILPOST | Mar 05, 1990 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K896693 | FLEXI-CAST CROWN CORE SYSTEM | Feb 14, 1990 | Substantially Equivalent | ESSENTIAL DENTAL SYSTEMS, INC. |
| K884277 | AD POST | Dec 22, 1988 | Substantially Equivalent | J. MORITA USA, INC. |
| K882125 | CENTRIX TRI-LAMINATE POST SYSTEM | Aug 11, 1988 | Substantially Equivalent | CENTRIX, INC. |
| K870130 | DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM | Feb 19, 1987 | Substantially Equivalent | DEN-MAT CORP. |
| K851038 | ARCEE DENTAL POST | Apr 29, 1985 | Substantially Equivalent | ARCEE DENTAL PRODUCTS CO. |
| K812092 | BETA POST | Aug 20, 1981 | Substantially Equivalent | PAUL B. HELLER, D.M.D. |
| K802515 | ROOT CANAL POST | Nov 12, 1980 | Substantially Equivalent | UNITEK CORP. |
FEI Numbers
This FDA classification entry is associated with 93 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 93 registration numbers. Click on an entry to view related FDA registrations.