Resin Teeth S PE S DCL

Basic Information

• Brand Name: Resin Teeth S PE S DCL
• Primary DI: DIVO7421461
• Version / Model: 742146
• Catalog Number: 742146
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• Labeler DUNS: 448015938
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2021-04-19
• Public Version: 2
• Public Version Date: 2022-03-16
• Public Version Status: Update
• Public Device Record Key: cb2cfed1-6613-444e-bac0-485be09b9378
• Distribution End Date: 2022-03-15

Device Description

SR Vivodent S DCL 6er O A13 A3, SR Vivodent S DCL 6er O A12 A3, SR Vivodent S DCL 6er O A66 A3, SR Vivodent S DCL 6er U A5 A3, SR Vivodent S DCL 6er U A6 A3, SR Vivodent S DCL 6er U A7 A3, SR Orthotyp S DCL 8er O N3U A3, SR Orthotyp S DCL 8er U N3L A3, SR Orthotyp S DCL 8er O N4U A3, SR Orthotyp S DCL 8er U N4L A3, SR Orthotyp S DCL 8er O N5U A3, SR Orthotyp S DCL 8er U N5L A3

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELM	Denture, plastic, teeth	Dental	872.3590	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38643	Resin artificial teeth	Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	DIVO7421460	HIBCC
Primary	DIVO7421461	HIBCC