FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
QUICK JET M
K Number: K133170
·
Decision Mar 28, 2014
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
258
Applicant Total
3
Review Days
162
Basic Information
- Device Name
- QUICK JET M
- K Number
- K133170
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MICRON CORP.
- Date Received
- October 17, 2013
- Decision Date
- March 28, 2014
- Product Code
- EFB
- 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 |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | FDA class 1 | Dental |
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