FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
FILE-EZE
K Number: K934415
·
Decision Apr 13, 1994
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
40
Applicant Total
103
Review Days
215
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Basic Information
- Device Name
- FILE-EZE
- K Number
- K934415
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ultradent Products, Inc.
- Date Received
- September 10, 1993
- Decision Date
- April 13, 1994
- Product Code
- KJJ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| KJJ | Cleanser, Root Canal | FDA unclassified | Unknown |
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