FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIMEX 2
K Number: K000454
·
Decision Mar 31, 2000
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
28
Review Days
49
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Basic Information
- Device Name
- DIMEX 2
- K Number
- K000454
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Planmeca Oy
- Date Received
- February 11, 2000
- Decision Date
- March 31, 2000
- Product Code
- MUH
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
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