FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040007089
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9004389
Catalog number
9004389
Device description
Caries Indicator Syr Kit
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LFCDEVICE, CARIES DETECTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFCDevice, Caries DetectionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040007089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1030404000708910304040007089

GMDN Terms#

Term, Definition table
TermDefinition
Dental caries detecting stainA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge22Gauge
Total Volume1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius24 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit75 Degrees Fahrenheit

Regulatory Flags#

DUNS number
012430880
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09359621000021BlueCheckINCISIVE TECHNOLOGIES PTY LTDLFC2025-02-26
09359621000038BlueCheckINCISIVE TECHNOLOGIES PTY LTDLFC2024-11-20
09359621000014BlueCheckINCISIVE TECHNOLOGIES PTY LTDLFC2024-11-20
00817051021690ExposeCENTRIX, INC.LFC2023-12-22
00817051021706ExposeCENTRIX, INC.LFC2023-12-22
00817051021744ExposeCENTRIX, INC.LFC2023-12-22
00817051022338ExposeCENTRIX, INC.LFC2023-12-22
00817051022345ExposeCENTRIX, INC.LFC2023-12-22
00817051022352ExposeCENTRIX, INC.LFC2023-12-22
00817051022369ExposeCENTRIX, INC.LFC2023-12-22
00858197004062Ortek Therapeutics, Inc. ORTEK THERAPEUTICS, INCLFC2022-12-21
10818207020854Vista Blue Unit Dose KitVista DentalLFC2021-01-29
10818207020861Vista Blue Fracture Detection KitVista DentalLFC2021-01-29
00304040027820Henry ScheinHENRY SCHEIN, INC.LFC2020-08-24
20304040027824Henry ScheinHENRY SCHEIN, INC.LFC2020-08-24
00304040133422Henry ScheinHENRY SCHEIN, INC.LFC2020-07-30
10304040133429Henry ScheinHENRY SCHEIN, INC.LFC2020-07-30
10818207020014Vista-Red Caries Indicator Standard PackVista DentalLFC2018-07-31
10818207020021Vista-Red Caries Refill PackVista DentalLFC2018-07-31
10818207020038Vista-Red Caries Value PackVista DentalLFC2018-07-31
10818207020045Vista-Red Caries Unit DoseVista DentalLFC2018-07-31
10818207020069Vista-Green Caries Indicator Standard KitVista DentalLFC2018-07-31
10818207020076Vista-Green Caries Indicator Refill PackVista DentalLFC2018-07-31
10818207020083Vista-Green Caries Indicator Value PackVista DentalLFC2018-07-31
10818207020090Vista-Green Unit DoseVista DentalLFC2018-07-31
10818207020380Mixing WellsVista DentalLFC2018-07-31
10818207020052Vista-Red Caries 10ml KitVista DentalLFC2018-06-19
10818207020106Vista-Green Caries Indicator 10ml KitVista DentalLFC2018-06-19
EKUR000220KA1CARIES DETECTORKURARAY NORITAKE DENTAL INC.LFC2017-02-17
D8097601RoydentROYDENT DENTAL PRODUCTS INCLFC2016-10-07