CORiTEC Splint Comfort

Basic Information

• Brand Name: CORiTEC Splint Comfort
• Primary DI: 01111111111116
• Version / Model: clear transparent, height 16 mm
• Catalog Number: PEMCR00016
• Company Name: pro3dure medical GmbH
• Labeler DUNS: 312947842
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-02
• Public Version: 1
• Public Version Date: 2022-09-12
• Public Version Status: New
• Public Device Record Key: 61ddf3e3-c47f-4e2d-abdf-fcfd95d98066

Device Description

CORiTEC disc, diameter 98.5 mm, height 16 mm

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQC	Mouthguard, Prescription	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
38620	Custom-made mouthguard	A custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	01111111111116	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K212017	000