Identity
- Trade Name
- GRADIA® FDA UDI
- Generic Name
- Root canal post, preformed FDA UDI
- Device Name
- GRADIA® GC FIBER POST Refills, 10 posts of one size, Diameter 1.4 FDA UDI
- Model / Reference
- 400005 FDA UDI
- Description
- GRADIA® GC FIBER POST Refills, 10 posts of one size, Diameter 1.4 FDA UDI
Identifiers
- Catalog Number
- 400005 FDA UDI
- Primary DI / UDI-DI
- 10386040008426 FDA UDI
- FDA Product Code
- ELR FDA UDI
- GMDN Term
- Root canal post, preformed FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Root canal post, preformed
Gradia® by Gc America Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Root canal post, preformed.
- AccessPost Overdenture — ESSENTIAL DENTAL SYSTEMS, INC. · Class I
- Hahnenkratt — E. Hahnenkratt GmbH · Class I
- FIBRAPOST PLUS N°1-4 (24 glass fibre posts + 4 reamers + 1 screwdiver) — Produits dentaires S.A. · Class I
- MACRO-LOCK OVAL INTRO KIT A — RECHERCHES TECHNIQUES DENTAIRES · Class I
- Flexi-Overdenture — ESSENTIAL DENTAL SYSTEMS, INC. · Class I
- FibreKleer 4x — KERR CORPORATION · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gc America Inc.
Sources (1)
- FDA UDI 922eaeb4-506f-46b5-9363-df09c847e3a9 36 fields · synced Jun 6, 2026