FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Salvin Tenting Screw System
K Number: K161857
·
Decision Apr 28, 2017
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
79
Applicant Total
2
Review Days
296
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Basic Information
- Device Name
- Salvin Tenting Screw System
- K Number
- K161857
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4880
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Salvin Dental Specialties
- Date Received
- July 6, 2016
- Decision Date
- April 28, 2017
- Product Code
- DZL
- 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 |
|---|---|---|---|
| DZL | Screw, Fixation, Intraosseous | FDA class 2 | Dental |
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Other Clearances by Salvin Dental Specialties
| K Number | Device Name | ||
|---|---|---|---|
| K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm | Sep 8, 2016 | Substantially Equivalent |