FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
R & D DESIGNATION AP-035
K Number: K010414
·
Decision Mar 27, 2001
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
17
Review Days
43
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Basic Information
- Device Name
- R & D DESIGNATION AP-035
- K Number
- K010414
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jensen Industries, Inc.
- Date Received
- February 12, 2001
- Decision Date
- March 27, 2001
- Product Code
- EJT
- 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | FDA class 2 | Dental |
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