FDA.reportPublic FDA data

The Orthodontic Store

Primary DI
10843471150853
Brand
The Orthodontic Store
Company
Young Innovations, Inc.
Model
J0497
Catalog number
J0497
Device description
Mint Gel Easy Etch 37% Blue 8Oz
Published
2022-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
10843471150853PackageGS11In Commercial Distribution
00843471150856PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084347115085310843471150853
00843471150856008434711508568434711508560843471150856

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 558-6684support@youngspecialties.com

Regulatory Flags#

DUNS number
004193103
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840326426200Young Specialties2000-02-102000-02-102026-01-26
10840326426217Young Specialties2000-03-102000-03-102026-01-26
10840326426224Young Specialties2000-04-102000-04-102026-01-26
10840326426231Young Specialties2000-05-102000-05-102026-01-26
10840326426248Young Specialties2000-06-102000-06-102026-01-26
10840326426255Young Specialties2000-07-102000-07-102026-01-26
10840326426262Young Specialties2000-08-102000-08-102026-01-26
10840326426279Young Specialties2000-09-102000-09-102026-01-26
10840326426286Young Specialties2000-10-102000-10-102026-01-26
10840326426293Young Specialties2000-15-102000-15-102026-01-26
00840326426302Young Specialties2000-16-102000-16-102026-01-26
10840326426316Young Specialties2000-17-102000-17-102026-01-26
10840326426323Young Specialties2000-18-102000-18-102026-01-26
10840326426330Young Specialties2000-19-102000-19-102026-01-26
10840326426347Young Specialties2000-20-102000-20-102026-01-26
10840326426354Young Specialties2000-21-102000-21-102026-01-26
10840326426361Young Specialties2000-22-102000-22-102026-01-26
10840326426378Young Specialties2000-23-102000-23-102026-01-26
10840326426385Young Specialties2000-24-102000-24-102026-01-26
10840326426392Young Specialties2000-25-102000-25-102026-01-26

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