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
10304040200589Henry Schein570609457060942026-10-06
10304040193843Henry Schein570560657056062026-10-05
10304040193850Henry Schein570560757056072026-10-05
10304040193867Henry Schein570560857056082026-10-05
10304040193874Henry Schein570560957056092026-10-05
10304040193881Henry Schein570561057056102026-10-05
10304040193898Henry Schein570561157056112026-10-05
10304040194109Henry Schein570562257056222026-10-05
10304040194116Henry Schein570562357056232026-10-05
10304040194208Henry Schein570569757056972026-10-05
10304040194215Henry Schein570569857056982026-10-05
10304040194222Henry Schein570569957056992026-10-05
10304040194239Henry Schein570570057057002026-10-05
10304040194246Henry Schein570570157057012026-10-05
10304040194253Henry Schein570570257057022026-10-05
10304040194260Henry Schein570570357057032026-10-05
10304040194277Henry Schein570570457057042026-10-05
10304040194284Henry Schein570570557057052026-10-05
10304040194291Henry Schein570570657057062026-10-05
10304040194307Henry Schein570570757057072026-10-05

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Primary DI, Brand, Company table
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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