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Obtura Spartan

FDA UDI

Class II (US FDA UDI)

by Obtura Spartan Endodontics

Identity

Trade Name
Obtura Spartan FDA UDI
Generic Name
Ultrasonic dental scaling/debridement system handpiece FDA UDI
Device Name
Autoclavable Endo Handpiece FDA UDI
Model / Reference
943-710 FDA UDI
Description
Autoclavable Endo Handpiece FDA UDI

Identifiers

Catalog Number
943-710 FDA UDI
Primary DI / UDI-DI
00816168020015 FDA UDI
FDA Product Code
ELC FDA UDI
GMDN Term
Ultrasonic dental scaling/debridement system handpiece 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ultrasonic dental scaling/debridement system handpiece

Obtura Spartan by Obtura Spartan Endodontics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic dental scaling/debridement system handpiece.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Obtura Spartan Endodontics

Sources (1)

  • FDA UDI fb665ce9-4c58-4f92-a960-6f0ff5ab2ba6 34 fields · synced May 30, 2026