Identity
- Trade Name
- Henry Schein EUDAMEDFDA UDI
- Generic Name
- Carbide dental bur, reusable FDA UDI
- Device Name
- Steel & TC Burs EUDAMEDCarbide Bur HP 8 FDA UDI
- Model / Reference
- 5700263 EUDAMEDFDA UDITF-010 EUDAMED
- Description
- Carbide Bur HP 8 FDA UDI
Identifiers
- Catalog Number
- 5700263 FDA UDI
- Primary DI / UDI-DI
- 10304040071806 EUDAMED00304040071809 FDA UDI
- Basic UDI-DI
- B-10304040071806 EUDAMED
- FDA Product Code
- EJL FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Carbide dental bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3240 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Category: Carbide dental bur, reusable
Henry Schein by Henry Schein, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Carbide dental bur, reusable.
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- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Carbide burs — DFS - DIAMON GmbH · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Henry Schein, Inc.
Sources (2)
- FDA UDI c78d2cbc-3ad8-44fa-a78b-d8d688317a13 34 fields · synced Oct 8, 2026
- EUDAMED 11c9c163-ce62-4591-81e9-7cc1ebf05ed4 61 fields · synced Oct 6, 2026