FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono
K Number: K232174
·
Decision Feb 23, 2024
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
18
Review Days
217
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Basic Information
- Device Name
- rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono
- K Number
- K232174
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genoss Co., Ltd.
- Date Received
- July 21, 2023
- Decision Date
- February 23, 2024
- Product Code
- EIH
- 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | FDA class 2 | Dental |
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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 |
| 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 |
| K170596 | TN-Brush | Sep 11, 2017 | Substantially Equivalent |
| K160079 | rainbow Shine | Nov 10, 2016 | Substantially Equivalent |