FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Bright MTA Sealer Plus
K Number: K231480
·
Decision Jul 28, 2023
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
18
Review Days
67
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Basic Information
- Device Name
- Bright MTA Sealer Plus
- K Number
- K231480
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genoss Co., Ltd.
- Date Received
- May 22, 2023
- Decision Date
- July 28, 2023
- Product Code
- KIF
- 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 |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
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|---|---|---|---|
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| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty | Dec 15, 2022 | Substantially Equivalent |
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| K200153 | Bright Bond Universal | Oct 28, 2020 | Substantially Equivalent |
| K200156 | Bright Low Flow | Oct 27, 2020 | Substantially Equivalent |
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