FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Vatech Clismile
K Number: K220689
·
Decision May 6, 2022
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
59
Applicant Total
38
Review Days
58
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Vatech Clismile
- K Number
- K220689
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rayence Co., Ltd.
- Date Received
- March 9, 2022
- Decision Date
- May 6, 2022
- Product Code
- NJM
- 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 |
|---|---|---|---|
| NJM | Bracket, Ceramic, Orthodontic | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NJM), ordered by most recent decision date.
LightForce Orthodontic System
FDA 510(k)
FDA Class 2
·Dental
Cleo
FDA 510(k)
FDA Class 2
·Dental
A-Line Advanced
FDA 510(k)
FDA Class 2
·Dental
DynaFlex Clear Brackets & Buttons
FDA 510(k)
FDA Class 2
·Dental
Ceramic Brackets Orthometric
FDA 510(k)
FDA Class 2
·Dental
LightForce Orthodontic System
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Rayence Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K243849 | 2430TCA with Xmaru W | Mar 12, 2025 | Substantially Equivalent |
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | Sep 9, 2024 | Substantially Equivalent |
| K240371 | 0909FCC, 0909FCC-HS | Mar 7, 2024 | Substantially Equivalent |
| K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF | Jun 21, 2023 | Substantially Equivalent |
| K212753 | 0909FCB, 1212FCA | Oct 18, 2021 | Substantially Equivalent |
| K202902 | 2430MCA with Xmaru W | Jun 21, 2021 | Substantially Equivalent |
| K210985 | 1717FCC | Apr 28, 2021 | Substantially Equivalent |
| K202722 | 1212FCA | Oct 26, 2020 | Substantially Equivalent |
| K201796 | 1717SCV, 1717SGV | Jul 23, 2020 | Substantially Equivalent |
| K190866 | XmaruView V1 (Xmaru Chiroview, Xmaru Podview) | Apr 30, 2019 | Substantially Equivalent |