Reline-it

Primary DI
00372494101960
Brand
Reline-it
Company
Doc Brands, 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
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
EBPReliner, Denture, Over The Counter

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00372494101960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00372494101960003724941019603724941019600372494101960

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
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
00372494101915Repair-it12022-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852305002018ProSoft Professional Denture RelinerPERMA LABORATORIES LLCEBP2018-06-14
00852305002070Perma Soft Denture RelinerPERMA LABORATORIES LLCEBP2018-06-14
00863995000109DenSureFitOTC DENTAL CORPORATIONEBP2017-01-23
00010705400968Reline-ItMAJESTIC DRUG CO. INC.EBP2016-07-27