Obtura Spartan

Basic Information

• Brand Name: Obtura Spartan
• Primary DI: 00816168020640
• Version / Model: 941-109
• Catalog Number: 941-109
• 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: e437cfa0-3e39-4a27-9154-ca895705ec4e

Device Description

Tip Set of 8 PST 1-8 Contains: 941-101 Tip PST-1 DI# 00816168020565 941-102 Tip PST-2 DI# 00816168020572 941-103 Tip PST-3 DI# 00816168020589 941-104 Tip PST-4 DI# 00816168020596 941-105 Tip PST-5 DI# 00816168020602 941-106 Tip PST-6 DI# 00816168020619 941-107 Tip PST-7 DI# 00816168020626 941-108 Tip PST-8 DI# 00816168020633

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
44908	Ultrasonic dental scaling/debridement system handpiece tip, periodontal	An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816168020640	GS1