CaviSense

Basic Information

• Brand Name: CaviSense
• Primary DI: 00860011755401
• Version / Model: 202410
• Company Name: Cavisense Inc.
• Labeler DUNS: 111292766
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-22
• Public Version: 1
• Public Version Date: 2024-10-30
• Public Version Status: New
• Public Device Record Key: 2d810764-50b6-4802-ba2d-255c692eac08

Device Description

Plaque disclosing device

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
QJC	Plaque Disclosing Agent	Dental	872.6855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60408	Dental caries detecting stain	A liquid substance intended for use in dentistry as a staining agent to detect early stage dental caries and/or to monitor the progress of caries. It typically consists of two solutions (e.g., metal fluorides) that are applied separately to the suspect area of the tooth/teeth, and change colour in the presence of the caries-producing bacteria or bacterial residues, and/or remnants of the tooth structure from a carious lesion. The staining produced can be monitored over time to assess the progression/remission of the caries. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860011755408	GS1	shipping case	16	In Commercial Distribution
Primary	00860011755401	GS1

Customer Contacts

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