Identity
- Trade Name
- Health-Tec/DHP Barbed Broaches FDA UDI
- Generic Name
- Endodontic broach, serrated, single-use FDA UDI
- Device Name
- Health-Tec/DHP Barbed Broaches XX-Fine 21mm Yellow 10/pkg FDA UDI
- Model / Reference
- 330-BB1XXF FDA UDI
- Description
- Health-Tec/DHP Barbed Broaches XX-Fine 21mm Yellow 10/pkg FDA UDI
Identifiers
- Catalog Number
- 330-BB1XXF FDA UDI
- Primary DI / UDI-DI
- D773330BB1XXF1 FDA UDI
- FDA Product Code
- EKW FDA UDI
- GMDN Term
- Endodontic broach, serrated, single-use 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
Yes
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: Endodontic broach, serrated, single-use
Health-Tec/DHP Barbed Broaches by Dental Health Products Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic broach, serrated, single-use.
- Dental City — ICP, INC. · Class I
- Barded Broach Maillefer — TULSA DENTAL PRODUCTS LLC · Class I
- Dental City — ICP, INC. · Class I
- Barded Broach Maillefer — TULSA DENTAL PRODUCTS LLC · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Barded Broach Maillefer — TULSA DENTAL PRODUCTS LLC · Class I
- Dental City — ICP, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dental Health Products Inc
Sources (1)
- FDA UDI ebfb2c52-65e9-4bff-b78c-6ae663b653d9 34 fields · synced May 30, 2026