FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
PAPAYA & PAPAYA Plus
K Number: K220423
·
Decision May 19, 2022
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
24
Review Days
94
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Basic Information
- Device Name
- PAPAYA & PAPAYA Plus
- K Number
- K220423
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genoray Co., Ltd.
- Date Received
- February 14, 2022
- Decision Date
- May 19, 2022
- Product Code
- MUH
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
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| K200469 | PAPAYA 3D Premium & PAPAYA 3D Premium Plus | Sep 16, 2020 | Substantially Equivalent |
| K181943 | OSCAR (OSCAR Prime, OSCAR Classic) | Aug 17, 2018 | Substantially Equivalent |