Identity
- Trade Name
- Obtura Spartan FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI
- Device Name
- Tip BUC-3 FDA UDI
- Model / Reference
- 930-043 FDA UDI
- Description
- Tip BUC-3 FDA UDI
Identifiers
- Catalog Number
- 930-043 FDA UDI
- Primary DI / UDI-DI
- 00816168020312 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Ultrasonic dental scaling/debridement system handpiece tip, endodontic
The Obtura Spartan is a tip BUC-3 ultrasonic dental scaling/debridement system handpiece, designed for use in endodontic procedures. This device provides effective removal of debris and calcified tissue from the root canal, promoting healthy healing and reducing the risk of complications.
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Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Obtura Spartan Endodontics
Sources (1)
- FDA UDI 661112ce-0038-4cb3-b46d-6dc8228f8d2e 34 fields · synced Jul 11, 2026