Ola Fresh Dental Appliance Cleanser OLA12

GUDID D805OLA120

The Ola Fresh Dental Appliance Cleanser is a concentrated cleaning powder for dissolution in water for the cleaning of dentures, partials, nightguards, sportsguards, snoreguards, aligners, and retainers.

THERMOPLASTIC COMFORT SYS

Denture cleanser
Primary Device IDD805OLA120
NIH Device Record Key2a117296-701f-455e-9dc9-c27def3a0390
Commercial Distribution StatusIn Commercial Distribution
Brand NameOla Fresh Dental Appliance Cleanser
Version Model NumberOLA12
Catalog NumberOLA12
Company DUNS808897776
Company NameTHERMOPLASTIC COMFORT SYS
Device Count12
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD805OLA120 [Unit of Use]
HIBCCD805OLA122 [Primary]

FDA Product Code

EFTCleanser, Denture, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-07
Device Publish Date2021-03-30

On-Brand Devices [Ola Fresh Dental Appliance Cleanser]

D805OLA240The Ola Fresh Dental Appliance Cleanser is a concentrated cleaning powder for dissolution in wat
D805OLA120The Ola Fresh Dental Appliance Cleanser is a concentrated cleaning powder for dissolution in wat
D805OLA010The Ola Fresh Dental Appliance Cleanser is a concentrated cleaning powder for dissolution in wat

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