10TEMP

Basic Information

• Brand Name: 10TEMP
• Primary DI: 08435288480121
• Version / Model: DISC C4 10 LAYERS 98,5/20mm
• Catalog Number: RGW10-C4-20
• Company Name: UNION DENTAL SA
• Labeler DUNS: 462114760
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-10
• Public Version: 2
• Public Version Date: 2021-10-29
• Public Version Status: Update
• Public Device Record Key: 226abe72-9942-4526-8ebf-98087274022b

Device Description

10TEMP RATAVA DISC 10 LAYERS COLOR C4 98,5/20mm

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
EBG	Crown And Bridge, Temporary, Resin	Dental	872.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31783	Temporary dental crown/bridge	A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08435288480121	GS1

Premarket Submissions

Submission Number	Supplement Number
K150432	000