FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
K Number: K233954
·
Decision Feb 13, 2024
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
399
Applicant Total
1
Review Days
60
Basic Information
- Device Name
- Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
- K Number
- K233954
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- B&E Korea Co., Ltd.
- Date Received
- December 15, 2023
- Decision Date
- February 13, 2024
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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