FDA.reportPublic FDA data

PERK Emergency Denture Repair Kit

Primary DI
00852305002117
Brand
PERK Emergency Denture Repair Kit
Company
PERMA LABORATORIES LLC
Model
pk6
Device description
A convenient collection of equipment and materials typically used in an emergency by a layperson to repair a damaged denture. It is available [non-prescription] over-the-counter (OTC) and enables the permanent repair of denture cracks and breaks without professional assistance. It typically consists of dental adhesive materials (e.g., a resin monomer system of powder and liquid glue) and mixing and application utensils. After application, this device cannot be reused.
Published
2018-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
EBODenture Repair Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBODenture Repair KitDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852305002117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852305002117008523050021178523050021170852305002117

GMDN Terms#

Term, Definition table
TermDefinition
Denture repair kit, home-useA convenient collection of equipment and materials typically used in an emergency by a layperson to repair a damaged denture. It is available [non-prescription] over-the-counter (OTC) and enables the permanent repair of denture cracks and breaks without professional assistance. It typically consists of dental adhesive materials (e.g., a resin monomer system of powder and liquid glue) and mixing and application utensils. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
111780698
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852305002018ProSoft Professional Denture Reliner2ps2018-06-14
00852305002070Perma Soft Denture Reliner4c2018-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00372494101915Repair-itDoc Brands, Inc.EBO2022-03-09
10887488954820CARDINAL HEALTHCardinal Health 200, LLCEBO2018-04-26
50887488954828CARDINAL HEALTHCardinal Health 200, LLCEBO2018-04-26
10887488844749CARDINAL HEALTHCardinal Health 200, LLCEBO2017-12-18
50887488844747CARDINAL HEALTHCardinal Health 200, LLCEBO2017-12-18
D8370640000Porcelain Etching PasteTaub ProductsEBO2016-12-05
D8370610000FUSION SilaneTaub ProductsEBO2016-10-26
D8370610020FUSION SilaneTaub ProductsEBO2016-10-26
D8370620000FUSION SilaneTaub ProductsEBO2016-10-26
D8370620010FUSION SilaneTaub ProductsEBO2016-10-26
D8370620100FUSION SilaneTaub ProductsEBO2016-10-26
D8370620110FUSION SilaneTaub ProductsEBO2016-10-26
D8370620200FUSION SilaneTaub ProductsEBO2016-10-26
00010705400913Repair-ItMAJESTIC DRUG CO. INC.EBO2016-07-27
20010705400917Repair-ItMAJESTIC DRUG CO. INC.EBO2016-07-27
10887488469638CARDINAL HEALTHCardinal Health 200, LLCEBO2016-07-01
50887488469636CARDINAL HEALTHCardinal Health 200, LLCEBO2016-07-01