Identity
- Trade Name
- Obtura Spartan FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI
- Device Name
- EMS Threaded Tip Set KiS 1-6E Contains: 932-011 Tip KiS-1E DI# 00816168020428 932-012 Tip KiS-2E DI# 00816168020435 932-013 Tip KiS-3E DI# 00816168020442 932-014 Tip KiS-4E DI# 00816168020459 932-015 Tip KiS-5E DI# 00816168020466 932-016 Tip KiS-6E DI# 00816168020473 FDA UDI
- Model / Reference
- 932-017 FDA UDI
- Description
- EMS Threaded Tip Set KiS 1-6E Contains: 932-011 Tip KiS-1E DI# 00816168020428 932-012 Tip KiS-2E DI# 00816168020435 932-013 Tip KiS-3E DI# 00816168020442 932-014 Tip KiS-4E DI# 00816168020459 932-015 Tip KiS-5E DI# 00816168020466 932-016 Tip KiS-6E DI# 00816168020473 FDA UDI
Identifiers
- Catalog Number
- 932-017 FDA UDI
- Primary DI / UDI-DI
- 00816168020664 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 47213680-c6b1-4928-ac82-049d478fee33 34 fields · synced Jun 8, 2026