Identity
- Trade Name
- TN-Brush FDA UDI
- Generic Name
- Dental prosthesis/orthodontic appliance cleaning brush FDA UDI
- Device Name
- DENTAL SCALER, ROTARY FDA UDI
- Model / Reference
- TN-0.8 FDA UDI
- Description
- DENTAL SCALER, ROTARY FDA UDI
Identifiers
- Catalog Number
- TN-0.8 FDA UDI
- Primary DI / UDI-DI
- 08809552960594 FDA UDI
- 510(k) Number
- K170596 FDA UDI
- FDA Product Code
- ELB FDA UDI
- GMDN Term
- Dental prosthesis/orthodontic appliance cleaning brush FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4840 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 3.5 Centimeter FDA UDI
Category: Dental prosthesis/orthodontic appliance cleaning brush
TN-Brush by Genoss — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis/orthodontic appliance cleaning brush.
- Denture Brushes — Dynarex Corp. · Class I
- TN-Brush — Genoss · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Genoss
Sources (1)
- FDA UDI 577de55d-e29d-4682-b9a9-61afbd102624 37 fields · synced May 30, 2026