FDA 510(k)
FDA class 1
Substantially Equivalent
🇰🇷 South Korea
STRONG DENTAL HANDPIECES
K Number: K100192
·
Decision Feb 4, 2010
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
72
Applicant Total
18
Review Days
13
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Basic Information
- Device Name
- STRONG DENTAL HANDPIECES
- K Number
- K100192
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Saeshin Precision Co., Ltd.
- Date Received
- January 22, 2010
- Decision Date
- February 4, 2010
- Product Code
- EGS
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | FDA class 1 | Dental |
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