FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
S-Line
K Number: K182193
·
Decision Jan 22, 2019
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
59
Applicant Total
4
Review Days
161
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Basic Information
- Device Name
- S-Line
- K Number
- K182193
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biocetec Co., Ltd.
- Date Received
- August 14, 2018
- Decision Date
- January 22, 2019
- 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 |
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