VITA CAD Temp

Basic Information

• Brand Name: VITA CAD Temp
• Primary DI: J017EC41M2TM40100
• Version / Model: EC41M2TM4010
• Company Name: Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
• Labeler DUNS: 315165357
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-18
• Public Version: 4
• Public Version Date: 2021-10-29
• Public Version Status: Update
• Public Device Record Key: b601a32e-5bd4-45a1-bd1b-42200b0474ae

Device Description

VITA CAD-Temp multiColor for CEREC/inLab, 1M2T, CTM-40, 10 pcs.

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: 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
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	J017EC41M2TM40100	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K070991	000