FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ZEN CORDLESS PROPHY SYSTEM
K Number: K101612
·
Decision Jun 30, 2010
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
5
Review Days
21
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Basic Information
- Device Name
- ZEN CORDLESS PROPHY SYSTEM
- K Number
- K101612
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Discus Dental, LLC
- Date Received
- June 9, 2010
- Decision Date
- June 30, 2010
- Product Code
- EKX
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | FDA class 1 | Dental |
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