FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)
K Number: K032995
·
Decision Nov 20, 2003
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
194
Applicant Total
3
Review Days
56
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Basic Information
- Device Name
- SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)
- K Number
- K032995
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micron Corp.
- Date Received
- September 25, 2003
- Decision Date
- November 20, 2003
- Product Code
- ELC
- 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 |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | FDA class 2 | Dental |
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