Identity
- Trade Name
- Spline® FDA UDI
- Generic Name
- Steel dental bur, reusable FDA UDI
- Model / Reference
- 2182 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889024013377 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Steel dental bur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
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: Steel dental bur, reusable
Spline® by Zimmer Dental Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Steel dental bur, reusable.
- Tru-Fix — ACE SURGICAL SUPPLY CO., INC. · Class I
- KLOCKNER — SOADCO, S.L. · Class I
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- House Brand Dentistry — Frontier Dental Supply Inc · Class I
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- House Brand Dentistry — Frontier Dental Supply Inc · Class I
- House Brand Dentistry — Frontier Dental Supply Inc · Class I
- BUSCH®, BNA® — BUSCH & CO. GmbH & Co. KG · 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
- Zimmer Dental Inc.
Sources (1)
- FDA UDI 4176542b-d820-425c-a732-4a5f4357d731 34 fields · synced Jun 1, 2026