CORiTEC PMMA Disc

Basic Information

• Brand Name: CORiTEC PMMA Disc
• Primary DI: D70952500598239
• Version / Model: CORiTEC PMMA Disc, shade D2 translucent thickness 20mm, diameter 98,5mm, with no
• Catalog Number: 52500598239
• Company Name: Merz Dental GmbH
• Labeler DUNS: 324914910
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-30
• Public Version: 4
• Public Version Date: 2021-12-13
• Public Version Status: Update
• Public Device Record Key: 2dfa491a-96f0-4ca2-bb6d-7c79181cced9

Device Description

CORiTEC PMMA Disc, shade D2 translucent thickness 20mm, diameter 98,5mm, with notch

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
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	D70952500598239	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K071548	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	98.5	Millimeter
Height	20	Millimeter