FDA.reportPublic FDA data

Repair-It

Primary DI
00010705400913
Brand
Repair-It
Company
MAJESTIC DRUG CO. INC.
Model
1
Device description
Repair-It Advanced Denture Repair Kit repairs broken dentures and denture teeth in minutes: Fix breaks, replace loose teeth, and mend cracks.
Published
2016-07-27
Public version status
Update
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
EBOOver The Counter Denture Repair Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBODenture Repair KitDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20010705400917PackageGS116In Commercial Distribution
30010705400914PackageGS116In Commercial Distribution
70010705400912PackageGS16In Commercial Distribution
00010705400913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2001070540091720010705400917
3001070540091430010705400914
7001070540091270010705400912
00010705400913000107054009130107054009130010705400913

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.

Contacts#

Phone, Email table
PhoneEmail
800-238-0220custserv@majesticdrug.com

Regulatory Flags#

DUNS number
001496777
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20010705400917Repair-It12016-07-27
00010705400968Reline-It12016-07-27
00010705400456SenzAway12016-07-27
00010705400708Recapit12016-07-27
00010705400814DenTemp Custom12016-07-27
00010705400852Dentemp12016-07-27
00010705400883Refilit12016-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00372494101915Repair-itDoc Brands, Inc.EBO2022-03-09
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
20010705400917Repair-ItMAJESTIC DRUG CO. INC.EBO2016-07-27
10887488469638CARDINAL HEALTHCardinal Health 200, LLCEBO2016-07-01
50887488469636CARDINAL HEALTHCardinal Health 200, LLCEBO2016-07-01