FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040005804
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1015396
Catalog number
1015396
Device description
Etch Gel Syringe Kit 40%
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KLEAGENT, TOOTH BONDING, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040005804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040005804003040400058043040400058040304040005804

GMDN Terms#

Term, Definition table
TermDefinition
Dental etching solutionAn acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge22Gauge

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815967022503PacBondPac-Dent, Inc.KLE2026-03-24
00815967023005PacBondPac-Dent, Inc.KLE2026-03-24
00815967027454RodinPac-Dent, Inc.KLE2026-03-24
00815967027461RodinPac-Dent, Inc.KLE2026-03-24
00815967027478RodinPac-Dent, Inc.KLE2026-03-24
00815967027485RodinPac-Dent, Inc.KLE2026-03-24
00815967022404PacEtchPac-Dent, Inc.KLE2026-03-23
00815967022411PacEtchPac-Dent, Inc.KLE2026-03-23
00815967022589PacEtchPac-Dent, Inc.KLE2026-03-23
00815967029984RodinPac-Dent, Inc.KLE2026-03-23
DVIV687778WW0Adhese Universal DCIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2026-03-17
DVIV687779WW0Adhese Universal DCIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2026-03-17
07290115050196Prima Quick PrimeB.J.M. LABORATORIES LTDKLE2026-03-13
07290115051889Smile Stream STEP-1 PumEtchB.J.M. LABORATORIES LTDKLE2026-03-13
00840479203409SELF ETCHING PRIMER REFILL CARTRIDGERELIANCE ORTHODONTIC PRODUCTS INCKLE2026-03-12
00840479203546ASSURE PLUS ALL SURFACE RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-03-12
00840481135286MICROPRIMEZest Anchors, LLCKLE2026-03-10
00840481135293MICROPRIMEZest Anchors, LLCKLE2026-03-10
00840479200767ASSURE UNIVERSAL BONDING RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-23
00840479200859BLUE ETCH GEL WITH BACRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-23
00840479200897ASSURE UNIVERSAL BONDING RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-23
00840479200781ASSURE PLUS ALL SURFACE RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479200798ASSURE PLUS ALL SURFACE RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479200804ASSURE PLUS ALL SURFACE RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479203591ULTRA SELF ETCHING PRIMERRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479203607ULTRA SELF ETCHING PRIMERRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479200071BLUE ETCH GEL WITH BACRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-18
00840479200088BLUE ETCH GEL WITH BACRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-18
00190746071003Acid EtchantAMERICAN ORTHODONTICS CORPORATIONKLE2026-01-28
00850079280120HexaHexa DentalKLE2026-01-21