FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE PROPHYLAXIS ANGLE
K Number: K951016
·
Decision May 2, 1995
Classifications
1
FEI Numbers
116
Registration Numbers
116
Same Product Code
7
Applicant Total
3
Review Days
57
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Basic Information
- Device Name
- DISPOSABLE PROPHYLAXIS ANGLE
- K Number
- K951016
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6290
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Preventive Technologies, Inc.
- Date Received
- March 6, 1995
- Decision Date
- May 2, 1995
- Product Code
- EHK
- 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 |
|---|---|---|---|
| EHK | Cup, Prophylaxis | FDA class 1 | Dental |
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