Obtura Spartan

Basic Information

• Brand Name: Obtura Spartan
• Primary DI: 00816168020022
• Version / Model: 943-610
• Catalog Number: 943-610
• Company Name: OBTURA SPARTAN ENDODONTICS
• Labeler DUNS: 078371330
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-03
• Public Version: 3
• Public Version Date: 2022-09-27
• Public Version Status: Update
• Public Device Record Key: 04cca474-07d2-4d94-a80c-9a6fc6900f66

Device Description

Autoclavable Scaling Handpiece

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELC	Scaler, Ultrasonic	Dental	872.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44907	Ultrasonic dental scaling/debridement system handpiece	A hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form of a pen/pencil with attached cables. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816168020022	GS1