BlueCheck

Basic Information

• Brand Name: BlueCheck
• Primary DI: 09359621000038
• Version / Model: BN01BUS
• Company Name: INCISIVE TECHNOLOGIES PTY LTD
• Labeler DUNS: 747210755
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2024-11-20
• Public Version: 1
• Public Version Date: 2024-11-28
• Public Version Status: New
• Public Device Record Key: 24dc5cfc-3388-48e7-9050-2966fb60efbd

Device Description

BlueCheck Caries Detection & Monitoring Medical Device Dental 0.3 mL x 10

Device Characteristics

• Single Use: Yes
• 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
LFC	Device, Caries Detection	Dental	872.1740	2

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
Unit of Use	09359621000014	GS1
Primary	09359621000038	GS1
Package	19359621000035	GS1	Shipper	140	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K222560	000