FDA.reportPublic FDA data

OrthoStore - MINT

Primary DI
00843471100035
Brand
OrthoStore - MINT
Company
YOUNG INNOVATIONS HOLDINGS LLC
Model
625-300
Catalog number
625-300
Device description
MINT
Published
2018-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940120000ALPHA-DENTWallace A. Erickson & Co.1994-02-25ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843471100035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843471100035008434711000358434711000350843471100035

GMDN Terms#

Term, Definition table
TermDefinition
Alginate dental impression materialA material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius2.7 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078739060
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843471100004OrthoStore - BUBBLEGUM 625-100 625-100 2018-02-19
00843471100011OrthoStore - COTTON CANDY 625-125625-1252018-02-19
00843471100028OrthoStore - STRAWBERRY 625-200625-2002018-02-19
00843471100042OrthoStore - GRAPE625-400625-4002018-02-19
00843471100059OrthoStore - ROOTBEER 625-450625-4502018-02-19
00843471100066OrthoStore - CHERRY 625-500625-5002018-02-19
00843471100073OrthoStore - WATERMELON625-650625-6502018-02-19
00843471100080OrthoStore- PINA-COLADA 625-700625-7002018-02-19
00843471100097Plak Smacker1001141001142018-02-13
00843471100103OrthoStore - REPLICA, NO FLAVOR ALGINATE625-963625-9632018-02-23
00843471100110OrthoStore - KROMATICA ALGINATE, No Flavor625-964625-9642018-02-23
00843471100127OrthoStore - REPLICA, MINT FLAVOR ALGINATE625-973625-9732018-02-23
00843471100134OrthoStore - KROMATICA ALGINATE, MINT625-974625-9742018-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456219973JMUJMU DENTAL, INCELW2026-07-07
00840456219980JMUJMU DENTAL, INCELW2026-07-07
00840456219997JMUJMU DENTAL, INCELW2026-07-07
00840456220009JMUJMU DENTAL, INCELW2026-07-07
00840456222232JMUJMU DENTAL, INCELW2026-07-07
00840456222249JMUJMU DENTAL, INCELW2026-07-07
00840456222256JMUJMU DENTAL, INCELW2026-07-07
00840456222263JMUJMU DENTAL, INCELW2026-07-07
00840456222270JMUJMU DENTAL, INCELW2026-07-07
00840456222287JMUJMU DENTAL, INCELW2026-07-07
00840456222294JMUJMU DENTAL, INCELW2026-07-07
00840456222300JMUJMU DENTAL, INCELW2026-07-07
D105VP9008MI4MacImpressSurgimac LLCELW2026-07-06
18016200021546KROMOPAN SIL putty soft (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021553KROMOPAN SIL putty hard (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021560KROMOPAN SIL superlight body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021577KROMOPAN SIL superlight body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021584KROMOPAN SIL light body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021591KROMOPAN SIL light body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021607KROMOPAN SIL regular body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021614KROMOPAN SIL regular body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021621KROMOPAN SIL heavy body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021638KROMOPAN SIL heavy body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021676KROMOPAN SIL putty soft (2x300ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021683KROMOPAN SIL putty hard (2x300ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021690KROMOPAN SIL superlight body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021706KROMOPAN SIL superlight body (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021713KROMOPAN SIL light body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021720KROMOPAN SIL light body ECONOMY PACK (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021737KROMOPAN SIL regular body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28