Identity
- Trade Name
- Sabur by 3D Dental FDA UDI
- Generic Name
- Carbide dental bur, reusable FDA UDI
- Device Name
- Sabur Carbide Burs FG #1558 100/Pk FDA UDI
- Model / Reference
- SB-FG1558-100 FDA UDI
- Description
- Sabur Carbide Burs FG #1558 100/Pk FDA UDI
Identifiers
- Catalog Number
- SB-FG1558-100 FDA UDI
- Primary DI / UDI-DI
- 00810126505729 FDA UDI
- FDA Product Code
- EJL FDA UDI
- GMDN Term
- Carbide dental bur, reusable 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Carbide dental bur, reusable
Sabur by 3D Dental by 3d Dental Designs And Development, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbide dental bur, reusable.
- EDENTA — EDENTA ETABLISSEMENT · Class I
- Alpen — Coltene/Whaledent Inc. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Alpen — Coltene/Whaledent Inc. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · 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
- 3d Dental Designs And Development, Llc
Sources (1)
- FDA UDI 1b815e9c-5596-4e82-a743-87eb729ed3f4 35 fields · synced May 30, 2026