Identity
- Trade Name
- Darby Dental Supply, LLC FDA UDI
- Generic Name
- Dental laboratory power tool system FDA UDI
- Device Name
- BUR CARB LAB HP TAPERED 18100 FDA UDI
- Model / Reference
- 9515240 FDA UDI
- Description
- BUR CARB LAB HP TAPERED 18100 FDA UDI
Identifiers
- Catalog Number
- 9515240 FDA UDI
- Primary DI / UDI-DI
- 00889813028728 FDA UDI
- FDA Product Code
- EJL FDA UDI
- GMDN Term
- Dental laboratory power tool system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3240 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
No
FDA UDI
Over-the-Counter
Yes
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
Category: Dental laboratory power tool system
Darby Dental Supply, LLC by Darby Dental Supply, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental laboratory power tool system.
- Young — YOUNG DENTAL MANUFACTURING I, LLC · Class I
- Pindex — Coltene/Whaledent Inc. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- OSADA EXL-M40 — OSADA ELECTRIC CO., LTD. · Class I
- Young — YOUNG DENTAL MANUFACTURING I, LLC · Class I
- Pindex — Coltene/Whaledent Inc. · Class I
- Young — YOUNG DENTAL MANUFACTURING I, LLC · Class I
- TRAUS SSG20 — Saeshin Precision Co., Ltd. · 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
- Darby Dental Supply, Llc
Sources (1)
- FDA UDI a5323272-c95b-4511-bfc6-d55ca3c6144e 35 fields · synced May 30, 2026