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
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
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