FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip
K Number: K192033
·
Decision Jun 9, 2020
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
48
Applicant Total
1
Review Days
315
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Basic Information
- Device Name
- Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip
- K Number
- K192033
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bennett Jacoby, Dds, Ms, Inc.
- Date Received
- July 30, 2019
- Decision Date
- June 9, 2020
- Product Code
- DZI
- 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 |
|---|---|---|---|
| DZI | Drill, Bone, Powered | FDA class 2 | Dental |
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