FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
TI-MAX Z45
K Number: K121901
·
Decision Feb 28, 2013
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
72
Applicant Total
40
Review Days
244
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Basic Information
- Device Name
- TI-MAX Z45
- K Number
- K121901
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nakanishi, Inc.
- Date Received
- June 29, 2012
- Decision Date
- February 28, 2013
- Product Code
- EGS
- 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 |
|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | FDA class 1 | Dental |
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