FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEW STETIC DENTAL AMALGAM ALLOY
K Number: K140125
·
Decision Apr 29, 2014
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
2
Applicant Total
3
Review Days
103
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Basic Information
- Device Name
- NEW STETIC DENTAL AMALGAM ALLOY
- K Number
- K140125
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- New Stetic
- Date Received
- January 16, 2014
- Decision Date
- April 29, 2014
- Product Code
- OIV
- 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 |
|---|---|---|---|
| OIV | Dental Amalgam | FDA class 2 | Dental |
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