ProSoft Professional Denture Reliner

Primary DI
00852305002018
Brand
ProSoft Professional Denture Reliner
Company
PERMA LABORATORIES LLC
Model
2ps
Device description
A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and 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 (ISO 1942-2, def 2.111). 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
EBPReliner, Denture, Over The Counter

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121318000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121318000PROSOFTPerma Laboratories2012-06-06EBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852305002018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852305002018008523050020188523050020180852305002018

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 is available [non-prescription] over-the-counter (OTC) and 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
1-800-988-9194permalabs@gmail.com

Regulatory Flags#

DUNS number
111780698
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852305002070Perma Soft Denture Reliner4c2018-06-14
00852305002117PERK Emergency Denture Repair Kitpk62018-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00372494101960Reline-itDoc Brands, Inc.EBP2022-03-09
00852305002070Perma Soft Denture RelinerPERMA LABORATORIES LLCEBP2018-06-14
00863995000109DenSureFitOTC DENTAL CORPORATIONEBP2017-01-23
00010705400968Reline-ItMAJESTIC DRUG CO. INC.EBP2016-07-27