Identity
- Trade Name
- Obtura Spartan FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI
- Device Name
- Tip Set KiS 1D-6D Contains: 931-011 Tip KiS-1D Diamond DI# 00816168020183 931-012 Tip KiS-2D Diamond DI# 00816168020190 931-013 Tip KiS-3D Diamond DI# 00816168020206 931-014 Tip KiS-4D Diamond DI# 00816168020213 931-015 Tip KiS-5D Diamond DI# 00816168020220 931-016 Tip KiS-6D Diamond DI# 00816168020237 FDA UDI
- Model / Reference
- 931-116 FDA UDI
- Description
- Tip Set KiS 1D-6D Contains: 931-011 Tip KiS-1D Diamond DI# 00816168020183 931-012 Tip KiS-2D Diamond DI# 00816168020190 931-013 Tip KiS-3D Diamond DI# 00816168020206 931-014 Tip KiS-4D Diamond DI# 00816168020213 931-015 Tip KiS-5D Diamond DI# 00816168020220 931-016 Tip KiS-6D Diamond DI# 00816168020237 FDA UDI
Identifiers
- Catalog Number
- 931-116 FDA UDI
- Primary DI / UDI-DI
- 00816168020152 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
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ultrasonic dental scaling/debridement system handpiece tip, endodontic
Obtura Spartan by Obtura Spartan Endodontics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Obtura Spartan Endodontics
Sources (1)
- FDA UDI 8746b198-771a-424e-b9d0-aecde16b151c 34 fields · synced Jun 8, 2026