FDA.reportPublic FDA data

Repair-it

Primary DI
00372494101915
Brand
Repair-it
Company
Doc Brands, Inc.
Model
1
Device description
Repair-it is an OTC denture repair kit for home use. The device consists of a material, such as a resin monomer system of powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks.
Published
2022-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
00372494101915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00372494101915003724941019153724941019150372494101915

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 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

Contacts#

Phone, Email table
PhoneEmail
833-362-2763consumeraffairs@doc-brands.com

Regulatory Flags#

DUNS number
081254601
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816161015131Ora-GUARD12022-03-09
00372494103452Dentemp SleepTight12023-01-03
00372494103469SleepTight Rx12023-01-03
00372494102271Dentemp Oral Care Kit12022-11-17
00372494101250Dentemp Floss Picks12022-08-22
00372494101700Recap-it12022-03-09
00372494101854Dentemp12022-03-09
00372494101885Refil-it12022-03-09
00372494101960Reline-it12022-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852305002117PERK Emergency Denture Repair KitPERMA LABORATORIES LLCEBO2018-06-14
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