FDA.reportPublic FDA data

Orthoquest

Primary DI
10840326406554
Brand
Orthoquest
Company
Young Innovations, Inc.
Model
K0123
Catalog number
K0123
Device description
Bubble Gum Alginate Flavor
Published
2022-11-24
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

Contact Domains#

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
10840326406554PackageGS11In Commercial Distribution
00840326406557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084032640655410840326406554
00840326406557008403264065578403264065570840326406557

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.

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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
00840326426630Astek1002991002992026-05-11
00840326423851Astek19025190252025-03-17
00840326423868Astek19026190262025-03-17
00840326423875Astek19027190272025-03-17
00840326423882Astek19028190282025-03-17
00843471150061Astek19000190002022-10-18
00843471150078Astek19005190052022-10-18
00843471150085Astek19001190012022-10-18
00843471150092Astek19006190062022-10-18
00840326426586Plak Smacker2000622026-04-20
00840326426593Plak Smacker2000632026-04-20
00840326426609Plak Smacker2000642026-04-20
00840326426616Plak Smacker2000652026-04-20
00840326426623Plak Smacker2000662026-04-20
00840326426203Young Specialties2000-02-102000-02-102026-01-26
00840326426210Young Specialties2000-03-102000-03-102026-01-26
00840326426227Young Specialties2000-04-102000-04-102026-01-26
00840326426234Young Specialties2000-05-102000-05-102026-01-26
00840326426241Young Specialties2000-06-102000-06-102026-01-26
00840326426258Young Specialties2000-07-102000-07-102026-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00304040194416Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194423Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194430Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194447Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
07506338322638VIVID JELMDC DENTALELW2026-07-20
07506338322645VIVID JELMDC DENTALELW2026-07-20
07506338322652VIVID JELMDC DENTALELW2026-07-20
07506338322669BLU JELMDC DENTALELW2026-07-20
07506338322676BLU JELMDC DENTALELW2026-07-20
07506338322690VIVID JELMDC DENTALELW2026-07-20
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