DEXIS CariVu 3-in-1 by KaVo U

Basic Information

• Brand Name: DEXIS CariVu 3-in-1 by KaVo U
• Primary DI: EKAV101317000
• Version / Model: 1.013.1700
• Catalog Number: NA
• Company Name: KaVo Dental GmbH
• Labeler DUNS: 333710619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-31
• Public Version: 4
• Public Version Date: 2021-11-08
• Public Version Status: Update
• Public Device Record Key: b4725b4d-9d83-4ae1-b057-a36a6a6d3d14

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: Yes
• Has Lot/Batch Number: No
• 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
NTK	Caries detector, laser light, transmission	Dental	872.1745	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33995	Dental caries detector, optical induced fluorescence	A mains electricity (AC-powered) device designed to determine the changes in the fluorescence of teeth enamel and dentine due to mineral loss, mainly for the diagnosis of early stage dental caries and/or to monitor the progress of caries. It consists of a light source (typically a laser) that elicits fluorescence in teeth, and a unit that quantifies the altered fluorescence of the carious tooth tissue.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EKAV101317000	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K182712	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius