CediTEC

Basic Information

• Brand Name: CediTEC
• Primary DI: E22160821
• Version / Model: 6082
• Catalog Number: 6082
• Company Name: VOCO GmbH
• Labeler DUNS: 316699578
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-11
• Public Version: 1
• Public Version Date: 2022-07-19
• Public Version Status: New
• Public Device Record Key: be53a3bf-6874-4bc6-8007-f8ce0f9c45fb

Device Description

Luting of prefabricated prosthetic teeth in denture basis, repair and extension of dental prosthesis

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	872.3760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17609	Denture reliner, hard	A denture relining material intended to be applied by a dentist or dental laboratory technician as a permanent coating or lining on the base or tissue-contact surface of a denture and which sets to a hard state. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E22160821	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K220743	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 23 Degrees Celsius