FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇮 Finland
PROSTYLE COMPACT
K Number: K961420
·
Decision Sep 10, 1996
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
28
Review Days
151
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Basic Information
- Device Name
- PROSTYLE COMPACT
- K Number
- K961420
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Planmeca Oy
- Date Received
- April 12, 1996
- Decision Date
- September 10, 1996
- Product Code
- EIA
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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