Patterson®

Basic Information

• Brand Name: Patterson®
• Primary DI: D66207041147017
• Version / Model: 70411470
• Catalog Number: 70411470
• Company Name: PATTERSON DENTAL SUPPLY, INC.
• Labeler DUNS: 171843584
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-08
• Public Version: 2
• Public Version Date: 2024-09-02
• Public Version Status: Update
• Public Device Record Key: 8e498f66-69a9-46c8-8757-d586b935507c

Device Description

MATERIAL, TOOTH SHADE, RESIN

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBF	Material, tooth shade, resin	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34799	Composite dental impression material	A thermoplastic material designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D66207041147017	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K113563	000