| Primary Device ID | D805OLA240 |
| NIH Device Record Key | 2a149a8e-a000-43c4-a383-ef44d1fba26f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ola Fresh Dental Appliance Cleanser |
| Version Model Number | OLA24 |
| Catalog Number | OLA24 |
| Company DUNS | 808897776 |
| Company Name | THERMOPLASTIC COMFORT SYS |
| Device Count | 24 |
| 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 | D805OLA240 [Unit of Use] |
| HIBCC | D805OLA244 [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 |