Identity
- Trade Name
- EdgeGates™ FDA UDI
- Generic Name
- Manual endodontic file/rasp, single-use FDA UDI
- Device Name
- EdgeGates™ #4; 32 mm FDA UDI
- Model / Reference
- EG0432 FDA UDI
- Description
- EdgeGates™ #4; 32 mm FDA UDI
Identifiers
- Catalog Number
- EG0432 FDA UDI
- Primary DI / UDI-DI
- 00818365026173 FDA UDI
- FDA Product Code
- DZA FDA UDI
- GMDN Term
- Manual endodontic file/rasp, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4130 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: Manual endodontic file/rasp, single-use
EdgeGates™ by US Endodontics, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual endodontic file/rasp, single-use.
- Hedstrom-Files — TULSA DENTAL PRODUCTS LLC · Class I
- Endodontic Hand Instrument — TULSA DENTAL PRODUCTS LLC · Class I
- Endodontic Hand Instruments — TULSA DENTAL PRODUCTS LLC · Class I
- 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- K-Files — TULSA DENTAL PRODUCTS LLC · Class I
- K-REAMERS — TULSA DENTAL PRODUCTS LLC · Class I
- K-Files — TULSA DENTAL PRODUCTS LLC · Class I
- Endodontic Hand Instrument — TULSA DENTAL PRODUCTS 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
- US Endodontics, LLC
Sources (1)
- FDA UDI 309c6b2e-6bf7-4fb5-9c2e-5a06cdf484c9 35 fields · synced Jun 8, 2026