Identity
- Trade Name
- Integra® Miltex® FDA UDI
- Generic Name
- Carbide dental bur, single-use FDA UDI
- Device Name
- Carbide Burs, Hand Piece, 35 - 5 Pack FDA UDI
- Model / Reference
- DHP35 FDA UDI
- Description
- Carbide Burs, Hand Piece, 35 - 5 Pack FDA UDI
Identifiers
- Catalog Number
- DHP35 FDA UDI
- Primary DI / UDI-DI
- 10381780510093 FDA UDI
- FDA Product Code
- EJL FDA UDI
- GMDN Term
- Carbide dental bur, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3240 FDA UDI
- Commercial Distribution
- Not 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
Moist Heat or Steam Sterilization FDA UDI
Integra® Miltex® by Integra LifeSciences Production Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI c9d191e0-0c11-499a-8c31-4e163c68f3fe 36 fields · synced Jun 9, 2026