CAD/CAM Crown PEEK

Basic Information

• Brand Name: CAD/CAM Crown PEEK
• Primary DI: 06975031820740
• Version / Model: /
• Company Name: Beijing Yingguan Dental Technology Co., Ltd.
• Labeler DUNS: 560456141
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-30
• Public Version: 1
• Public Version Date: 2022-10-10
• Public Version Status: New
• Public Device Record Key: 1f9b02cb-d845-4414-b92f-1f35e080b4c1

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ozone, Ultraviolet Light

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NSN	Restoration, Resin, Crown And Bridge	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
38595	Custom-made dental crown, polymer	A device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06975031820740	GS1