DEVICE: TN-Brush (08809552960600)
Device Identifier (DI) Information
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 34879 | Dental prosthesis/orthodontic appliance cleaning brush |
A hand-held instrument comprised of a proximal handle and distal bristles intended to be used to manually clean a removable dental prosthesis (e.g., denture) and/or orthodontic appliance (e.g., retainer, aligner). It is intended to be used in the home and healthcare facility. This is a reusable device.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| ELB | SCALER, ROTARY |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K170596 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 1 and 30 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Length: 3.5 Centimeter |
Device Record Status
fd86b412-bda3-4797-b7b3-689ac44fccbf
August 05, 2022
3
July 10, 2018
August 05, 2022
3
July 10, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined