DTS, RESTORATION, PORCELAIN-FUSED

Basic Information

• Brand Name: DTS, RESTORATION, PORCELAIN-FUSED
• Primary DI: 06977512700084
• Version / Model: Porcelain Fused to
• Company Name: DTS Digital Dental Lab
• Labeler DUNS: 617176585
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-13
• Public Version: 1
• Public Version Date: 2024-06-21
• Public Version Status: New
• Public Device Record Key: 0dff6e35-a416-4b48-a8d1-32051539381a

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
38614	Dental bridge, metal-ceramic	A custom-made, non-removable, artificial replacement for one or more missing teeth made of metal alloy combined with tooth-coloured ceramic material (veneer), and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06977512700084	GS1