Home GUDID 09359621000014 BlueCheck
Primary DI 09359621000014
Brand BlueCheck
Company INCISIVE TECHNOLOGIES PTY LTD
Model BN01BUS
Device description BlueCheck Caries Detection & Monitoring Medical Device Dental 0.3 mL x 10
Published 2024-11-20
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name LFC Device, Caries Detection
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LFC Device, Caries Detection Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 19359621000035 Package GS1 140 In Commercial Distribution 09359621000038 Primary GS1 0 09359621000014 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 19359621000035 19359621000035 09359621000038 09359621000038 9359621000038 09359621000014 09359621000014 9359621000014
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 747210755 Device count 10 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 09359621000021 BlueCheck BN01AUS 2025-02-26 09359621000038 BlueCheck BN01BUS 2024-11-20
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 09359621000021 BlueCheck INCISIVE TECHNOLOGIES PTY LTD LFC 2025-02-26 09359621000038 BlueCheck INCISIVE TECHNOLOGIES PTY LTD LFC 2024-11-20 00817051021690 Expose CENTRIX, INC. LFC 2023-12-22 00817051021706 Expose CENTRIX, INC. LFC 2023-12-22 00817051021744 Expose CENTRIX, INC. LFC 2023-12-22 00817051022338 Expose CENTRIX, INC. LFC 2023-12-22 00817051022345 Expose CENTRIX, INC. LFC 2023-12-22 00817051022352 Expose CENTRIX, INC. LFC 2023-12-22 00817051022369 Expose CENTRIX, INC. LFC 2023-12-22 00858197004062 Ortek Therapeutics, Inc. ORTEK THERAPEUTICS, INC LFC 2022-12-21 10818207020854 Vista Blue Unit Dose Kit Vista Dental LFC 2021-01-29 10818207020861 Vista Blue Fracture Detection Kit Vista Dental LFC 2021-01-29 00304040027820 Henry Schein HENRY SCHEIN, INC. LFC 2020-08-24 20304040027824 Henry Schein HENRY SCHEIN, INC. LFC 2020-08-24 00304040133422 Henry Schein HENRY SCHEIN, INC. LFC 2020-07-30 10304040133429 Henry Schein HENRY SCHEIN, INC. LFC 2020-07-30 10818207020014 Vista-Red Caries Indicator Standard Pack Vista Dental LFC 2018-07-31 10818207020021 Vista-Red Caries Refill Pack Vista Dental LFC 2018-07-31 10818207020038 Vista-Red Caries Value Pack Vista Dental LFC 2018-07-31 10818207020045 Vista-Red Caries Unit Dose Vista Dental LFC 2018-07-31 10818207020069 Vista-Green Caries Indicator Standard Kit Vista Dental LFC 2018-07-31 10818207020076 Vista-Green Caries Indicator Refill Pack Vista Dental LFC 2018-07-31 10818207020083 Vista-Green Caries Indicator Value Pack Vista Dental LFC 2018-07-31 10818207020090 Vista-Green Unit Dose Vista Dental LFC 2018-07-31 10818207020380 Mixing Wells Vista Dental LFC 2018-07-31 10818207020052 Vista-Red Caries 10ml Kit Vista Dental LFC 2018-06-19 10818207020106 Vista-Green Caries Indicator 10ml Kit Vista Dental LFC 2018-06-19 EKUR000220KA1 CARIES DETECTOR KURARAY NORITAKE DENTAL INC. LFC 2017-02-17 D8097601 Roydent ROYDENT DENTAL PRODUCTS INC LFC 2016-10-07 D8097651 Roydent ROYDENT DENTAL PRODUCTS INC LFC 2016-10-07