FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Bright Bond Universal
K Number: K200153
·
Decision Oct 28, 2020
Classifications
1
FEI Numbers
133
Registration Numbers
133
Same Product Code
410
Applicant Total
3
Review Days
280
Basic Information
- Device Name
- Bright Bond Universal
- K Number
- K200153
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GENOSS Co., Ltd.
- Date Received
- January 22, 2020
- Decision Date
- October 28, 2020
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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