FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
TN-Brush
K Number: K170596
·
Decision Sep 11, 2017
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
5
Applicant Total
18
Review Days
195
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TN-Brush
- K Number
- K170596
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4840
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Genoss Co., Ltd.
- Date Received
- February 28, 2017
- Decision Date
- September 11, 2017
- Product Code
- ELB
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ELB | Scaler, Rotary | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ELB), ordered by most recent decision date.
TIGRAN PERIBRUSH
FDA 510(k)
FDA Class 2
·Dental
STRAUMANN TIBRUSH
FDA 510(k)
FDA Class 2
·Dental
MINIENDO III
FDA 510(k)
FDA Class 2
·Dental
AIR BURBINE HANDPIECE-DENTAL SCALING
FDA 510(k)
FDA Class 2
·Dental
ROTARY SCALER
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Genoss Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242386 | Bluemoon | May 5, 2025 | Substantially Equivalent |
| K222688 | The Trust | Aug 9, 2024 | Substantially Equivalent |
| K233885 | rainbow Paste Stain SE | Jun 21, 2024 | Substantially Equivalent |
| K232174 | rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono | Feb 23, 2024 | Substantially Equivalent |
| K231480 | Bright MTA Sealer Plus | Jul 28, 2023 | Substantially Equivalent |
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty | Dec 15, 2022 | Substantially Equivalent |
| K200155 | Bright High Flow | Nov 30, 2020 | Substantially Equivalent |
| K200153 | Bright Bond Universal | Oct 28, 2020 | Substantially Equivalent |
| K200156 | Bright Low Flow | Oct 27, 2020 | Substantially Equivalent |
| K160079 | rainbow Shine | Nov 10, 2016 | Substantially Equivalent |