Identity
- Trade Name
- EdgeV-File HT™ FDA UDI
- Generic Name
- Synthetic gutta-percha FDA UDI
- Device Name
- EdgeV-File HT™ Gutta Percha Points 30.08 FDA UDI
- Model / Reference
- EVHTGP3008 FDA UDI
- Description
- EdgeV-File HT™ Gutta Percha Points 30.08 FDA UDI
Identifiers
- Catalog Number
- EVHTGP3008 FDA UDI
- Primary DI / UDI-DI
- 00818365027699 FDA UDI
- FDA Product Code
- EKM FDA UDI
- GMDN Term
- Synthetic gutta-percha FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3850 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Synthetic gutta-percha
EdgeV-File HT™ by US Endodontics, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic gutta-percha.
- Gutta Percha Points — ROYDENT DENTAL PRODUCTS INC · Class I
- Roydent Gutta Percha — ROYDENT DENTAL PRODUCTS INC · Class I
- Vortex Blue Conform Fit — TULSA DENTAL PRODUCTS LLC · Class I
- MX 06-20 — Meta Biomed, Inc. · Class I
- Safco gutta percha points — Safco Dental Supply · Class I
- Vortex Blue Conform Fit — TULSA DENTAL PRODUCTS LLC · Class I
- Gutta Percha Points — TULSA DENTAL PRODUCTS LLC · Class I
- Gutta Percha 02-80 — Meta Biomed, Inc. · 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 |
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Manufacturer
- Manufacturer
- US Endodontics, LLC
Sources (1)
- FDA UDI a70fcc84-57a6-459f-ae65-8c54e192370c 35 fields · synced May 31, 2026