FDA.reportPublic FDA data

Young Innovations

Primary DI
00840326405949
Brand
Young Innovations
Company
Young Innovations, Inc.
Model
243225
Catalog number
243225
Device description
PLK SMACK 2 TONE TAB 250CT
Published
2024-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
QJCPlaque Disclosing Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJCPlaque Disclosing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840326405946PackageGS1250In Commercial Distribution
20840326405943PackageGS160In Commercial Distribution
00840326405949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084032640594610840326405946
2084032640594320840326405943
00840326405949008403264059498403264059490840326405949

GMDN Terms#

Term, Definition table
TermDefinition
Dental caries detecting stainA liquid substance intended for use in dentistry as a staining agent to detect early stage dental caries and/or to monitor the progress of caries. It typically consists of two solutions (e.g., metal fluorides) that are applied separately to the suspect area of the tooth/teeth, and change colour in the presence of the caries-producing bacteria or bacterial residues, and/or remnants of the tooth structure from a carious lesion. The staining produced can be monitored over time to assess the progression/remission of the caries. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 325-1881customerservice@younginnovations.com

Regulatory Flags#

DUNS number
004193103
Device count
1
Premarket exempt
true
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
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
D2486056550Quick-DetectHAGER WORLDWIDE, INC.QJC2025-10-20
D2486056621Quick-DetectHAGER WORLDWIDE, INC.QJC2025-10-20
D2486057651Quick-DetectHAGER WORLDWIDE, INC.QJC2025-10-20
D2486057681Quick-DetectHAGER WORLDWIDE, INC.QJC2025-10-08
00302732311028Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732322000Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732322109Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732322253Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732330043Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732342008Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732342107Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732342251Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732957189Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
20302732311022Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
20302732322004Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
10302732322106Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
10302732322250Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
10302732330040Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732331026Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
20302732342002Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
10302732342104Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
10302732342258Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
10302732957186Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
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07640159162803DISCLOSING TABLETS - 1'000 piecesProduits dentaires S.A.QJC2022-06-15
07640159162810DISCLOSING TABLETS - 500 piecesProduits dentaires S.A.QJC2022-06-15
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00723797010419HurriViewBEUTLICH PHARMACEUTICALS, LLCQJC2019-10-01