FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
Evogue Dental Unit
K Number: K152100
·
Decision Jan 22, 2016
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
4
Review Days
178
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Basic Information
- Device Name
- Evogue Dental Unit
- K Number
- K152100
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Takara Belmont Corporation
- Date Received
- July 28, 2015
- Decision Date
- January 22, 2016
- 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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