Identity
- Trade Name
- BARBED BROACHES FDA UDI
- Generic Name
- Endodontic broach, serrated, reusable FDA UDI
- Device Name
- Designed to remove pulp tissue. FDA UDI
- Model / Reference
- 21m/m 25/40(XXXF/F) FDA UDI
- Description
- Designed to remove pulp tissue. FDA UDI
Identifiers
- Catalog Number
- 504-092 FDA UDI
- Primary DI / UDI-DI
- 08806383520522 FDA UDI
- FDA Product Code
- EKW FDA UDI
- GMDN Term
- Endodontic broach, serrated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endodontic broach, serrated, reusable
Barbed Broaches by DiaDent Group International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic broach, serrated, reusable.
- RISPI SONIC — MICRO MEGA · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Barbed Broaches, 2-4, 25 — ENDOPERFECTION LIMITED · Class I
- RISPI SONIC — MICRO MEGA · Class I
- OPTIMUM — BENCO DENTAL SUPPLY CO. · Class I
- KOMET Root Canal Files — Gebr. Brasseler GmbH & Co. KG · Class I
- Barbed broaches 31mm 030, pu: 6 pcs — Diaswiss SA · 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
- DiaDent Group International
Sources (1)
- FDA UDI 8498f8f9-b465-48da-87d0-f74a055c0456 34 fields · synced Jun 6, 2026