ProSoft Professional Denture Reliner

GUDID 00852305002018

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.

PERMA LABORATORIES LLC

Denture reliner, soft, home-use
Primary Device ID00852305002018
NIH Device Record Key698f4e6c-43b2-4bf0-a337-f1bda560f0ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameProSoft Professional Denture Reliner
Version Model Number2ps
Company DUNS111780698
Company NamePERMA LABORATORIES LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-988-9194
Emailpermalabs@gmail.com
Phone1-800-988-9194
Emailpermalabs@gmail.com
Phone1-800-988-9194
Emailpermalabs@gmail.com
Phone1-800-988-9194
Emailpermalabs@gmail.com
Phone1-800-988-9194
Emailpermalabs@gmail.com
Phone1-800-988-9194
Emailpermalabs@gmail.com
Phone1-800-988-9194
Emailpermalabs@gmail.com
Phone1-800-988-9194
Emailpermalabs@gmail.com
Phone1-800-988-9194
Emailpermalabs@gmail.com
Phone1-800-988-9194
Emailpermalabs@gmail.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100852305002018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBPReliner, Denture, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-08-09
Device Publish Date2018-06-14

Devices Manufactured by PERMA LABORATORIES LLC

00852305002018 - ProSoft Professional Denture Reliner2018-08-09A 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.
00852305002018 - ProSoft Professional Denture Reliner2018-08-09 A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the b
00852305002070 - Perma Soft Denture Reliner2018-08-09 A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the b
00852305002117 - PERK Emergency Denture Repair Kit2018-07-16 A convenient collection of equipment and materials typically used in an emergency by a layperson to repair a damaged denture. It

Trademark Results [ProSoft Professional Denture Reliner]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROSOFT PROFESSIONAL DENTURE RELINER
PROSOFT PROFESSIONAL DENTURE RELINER
97239877 not registered Live/Pending
Perma Laboratories, LLC
2022-01-26
PROSOFT PROFESSIONAL DENTURE RELINER
PROSOFT PROFESSIONAL DENTURE RELINER
85219553 4034166 Dead/Cancelled
Perma Laboratories, LLC
2011-01-18

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