FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇺 Australia
NIL
K Number: K935687
·
Decision Feb 3, 1994
Classifications
1
FEI Numbers
357
Registration Numbers
357
Same Product Code
11
Applicant Total
1
Review Days
66
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Basic Information
- Device Name
- NIL
- K Number
- K935687
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dentalsafe Systems Pty., Ltd.
- Date Received
- November 29, 1993
- Decision Date
- February 3, 1994
- Product Code
- EAX
- 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 |
|---|---|---|---|
| EAX | Mirror, Mouth | FDA class 1 | Dental |
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