Reline-It

Primary DI
00010705400968
Brand
Reline-It
Company
MAJESTIC DRUG CO. INC.
Model
1
Device description
The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand.
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
EBPReliner, Denture, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBPReliner, Denture, Over The CounterDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101771000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101771000RELINE-IT MODEL RELINE-ITMajestic Drug Co., Inc.2010-09-20EBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20010705400962PackageGS116In Commercial Distribution
30010705400969PackageGS116In Commercial Distribution
40010705400966PackageGS16In Commercial Distribution
50010705400963PackageGS16In Commercial Distribution
00010705400968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2001070540096220010705400962
3001070540096930010705400969
4001070540096640010705400966
5001070540096350010705400963
00010705400968000107054009680107054009680010705400968

GMDN Terms#

Term, Definition table
TermDefinition
Denture reliner, soft, home-useA denture relining material such as plastic resin intended to be self-applied at home as a permanent coating or lining on the base or tissue-contact surface of a denture for improved fitting, and which sets to a soft, plastic state. It will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
001496777
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00010705400913Repair-It12016-07-27
20010705400917Repair-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
00372494101960Reline-itDoc Brands, Inc.EBP2022-03-09
00852305002018ProSoft Professional Denture RelinerPERMA LABORATORIES LLCEBP2018-06-14
00852305002070Perma Soft Denture RelinerPERMA LABORATORIES LLCEBP2018-06-14
00863995000109DenSureFitOTC DENTAL CORPORATIONEBP2017-01-23