FDA UDI
In Commercial Distribution
🇺🇸 United States
TCS Fresh Concentrated Dental Appliance Cleaner
DI: D8054505FRSMP6
·
Model: 4505FR-SMP
·
THERMOPLASTIC COMFORT SYS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
75
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Basic Information
- Brand Name
- TCS Fresh Concentrated Dental Appliance Cleaner
- Primary DI
- D8054505FRSMP6
- Version / Model
- 4505FR-SMP
- Catalog Number
- 4505FR-SMP
- Company Name
- THERMOPLASTIC COMFORT SYS
- Labeler DUNS
- 808897776
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 75
- Record Status
- Published
- Publish Date
- 2021-03-30
- Public Version
- 1
- Public Version Date
- 2021-04-07
- Public Version Status
- New
- Public Device Record Key
- 6ef50830-f04b-4537-8594-6fd93fc8b776
Device Description
The TCS Fresh Concentrated Dental Appliance Cleaner is a concentrated cleaning powder for dissolution in water for the cleaning of dentures, partials, nightguards, sportsguards, snoreguards, aligners, and retainers.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFT | Cleanser, Denture, Over The Counter | Dental | 872.3520 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35871 | Denture cleanser | An agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D8054505FRSMP0 | HIBCC | ||||
| Primary | D8054505FRSMP6 | HIBCC |
Customer Contacts
- Phone
- 562-426-2970
- [email protected]