FDA.reportPublic FDA data

Henry Schein

Primary DI
20304040027824
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702110
Catalog number
5702110
Device description
Caries Indicator Syringe Red
Published
2020-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
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
20304040027824PackageGS130In Commercial Distribution
00304040027820PrimaryGS10
10304040027827Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404002782420304040027824
00304040027820003040400278203040400278200304040027820
1030404002782710304040027827

GMDN Terms#

Term, Definition table
TermDefinition
Dental caries detector, optical induced fluorescenceA mains electricity (AC-powered) device designed to determine the changes in the fluorescence of teeth enamel and dentine due to mineral loss, mainly for the diagnosis of early stage dental caries and/or to monitor the progress of caries. It consists of a light source (typically a laser) that elicits fluorescence in teeth, and a unit that quantifies the altered fluorescence of the carious tooth tissue.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
4
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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

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
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
D8097651RoydentROYDENT DENTAL PRODUCTS INCLFC2016-10-07