Primary Device ID | D805OLA120 |
NIH Device Record Key | 2a117296-701f-455e-9dc9-c27def3a0390 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ola Fresh Dental Appliance Cleanser |
Version Model Number | OLA12 |
Catalog Number | OLA12 |
Company DUNS | 808897776 |
Company Name | THERMOPLASTIC COMFORT SYS |
Device Count | 12 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 562-426-2970 |
info@tcsdentalinc.com | |
Phone | 562-426-2970 |
info@tcsdentalinc.com | |
Phone | 562-426-2970 |
info@tcsdentalinc.com | |
Phone | 562-426-2970 |
info@tcsdentalinc.com | |
Phone | 562-426-2970 |
info@tcsdentalinc.com | |
Phone | 562-426-2970 |
info@tcsdentalinc.com | |
Phone | 562-426-2970 |
info@tcsdentalinc.com | |
Phone | 562-426-2970 |
info@tcsdentalinc.com | |
Phone | 562-426-2970 |
info@tcsdentalinc.com | |
Phone | 562-426-2970 |
info@tcsdentalinc.com | |
Phone | 562-426-2970 |
info@tcsdentalinc.com | |
Phone | 562-426-2970 |
info@tcsdentalinc.com | |
Phone | 562-426-2970 |
info@tcsdentalinc.com | |
Phone | 562-426-2970 |
info@tcsdentalinc.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D805OLA120 [Unit of Use] |
HIBCC | D805OLA122 [Primary] |
EFT | Cleanser, Denture, Over The Counter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-04-07 |
Device Publish Date | 2021-03-30 |
D805OLA240 | The Ola Fresh Dental Appliance Cleanser is a concentrated cleaning powder for dissolution in wat |
D805OLA120 | The Ola Fresh Dental Appliance Cleanser is a concentrated cleaning powder for dissolution in wat |
D805OLA010 | The Ola Fresh Dental Appliance Cleanser is a concentrated cleaning powder for dissolution in wat |