Universal Precision Composite Instrument Series

Basic Information

• Brand Name: Universal Precision Composite Instrument Series
• Primary DI: 07540172012843
• Version / Model: 062910
• Catalog Number: 062910
• Company Name: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
• Labeler DUNS: 626406016
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-17
• Public Version: 2
• Public Version Date: 2022-11-01
• Public Version Status: Update
• Public Device Record Key: 9953e150-135f-4c12-adcf-bf31a7ff9b7f
• Distribution End Date: 2022-10-31

Device Description

Dental restorative material applicator

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZN	INSTRUMENTS, DENTAL HAND	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63953	Dental material application tool, reusable	A hand-held manual dental instrument intended to be used for the application of a dental material (e.g., composite resin) to a dental prosthesis or to a patient’s tooth/teeth; the material is not included. It includes a handle with an application tip which holds the material on its surface; it is not a syringe- or pistol-like device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540172012843	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]