FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
E-STATIS 40 SYSTEM
K Number: K090937
·
Decision Jul 24, 2009
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
60
Applicant Total
11
Review Days
112
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Basic Information
- Device Name
- E-STATIS 40 SYSTEM
- K Number
- K090937
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scican , Ltd.
- Date Received
- April 3, 2009
- Decision Date
- July 24, 2009
- Product Code
- EBW
- 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 |
|---|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | FDA class 1 | Dental |
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