FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
RAYDENT SW
K Number: K233625
·
Decision May 16, 2024
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
33
Applicant Total
24
Review Days
185
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Basic Information
- Device Name
- RAYDENT SW
- K Number
- K233625
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ray Co., Ltd.
- Date Received
- November 13, 2023
- Decision Date
- May 16, 2024
- Product Code
- PNN
- 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 |
|---|---|---|---|
| PNN | Orthodontic Software | FDA class 2 | Dental |
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Other Clearances by Ray Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260462 | RCT800 | Apr 9, 2026 | Substantially Equivalent |
| K251798 | RCT700 | Nov 25, 2025 | Substantially Equivalent |
| K251109 | SMARTDent | May 21, 2025 | Substantially Equivalent |
| K243903 | RCT600 | Mar 12, 2025 | Substantially Equivalent |
| K232325 | RAYSCAN a-Expert | Apr 18, 2024 | Substantially Equivalent |
| K232287 | RAYSCAN a-Expert3D | Aug 31, 2023 | Substantially Equivalent |
| K230753 | RCT800 | Apr 11, 2023 | Substantially Equivalent |
| K213226 | RCT700 | Nov 29, 2021 | Substantially Equivalent |
| K211105 | Ear-Friendly Mask | May 17, 2021 | Substantially Equivalent |
| K192737 | RCT800 | Oct 22, 2019 | Substantially Equivalent |