FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
LUXEN Zr, LUXEN Smile
K Number: K171585
·
Decision Oct 31, 2018
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
3
Review Days
518
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Basic Information
- Device Name
- LUXEN Zr, LUXEN Smile
- K Number
- K171585
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentalmax Co., Ltd.
- Date Received
- May 31, 2017
- Decision Date
- October 31, 2018
- Product Code
- EIH
- 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | FDA class 2 | Dental |
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