FDA.reportPublic FDA data

OrthoStore - BUBBLEGUM

Primary DI
00843471100004
Brand
OrthoStore - BUBBLEGUM
Company
YOUNG INNOVATIONS HOLDINGS LLC
Model
625-100
Catalog number
625-100
Device description
BUBBLEGUM
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
00843471100004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843471100004008434711000048434711000040843471100004

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
00843471100011OrthoStore - COTTON CANDY 625-125625-1252018-02-19
00843471100028OrthoStore - STRAWBERRY 625-200625-2002018-02-19
00843471100035OrthoStore - MINT 625-300625-3002018-02-19
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

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