FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH
K Number: K936076
·
Decision Jan 26, 1994
Classifications
1
FEI Numbers
343
Registration Numbers
344
Same Product Code
53
Applicant Total
1
Review Days
37
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Basic Information
- Device Name
- ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH
- K Number
- K936076
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6865
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ohio Health Care Products, Inc.
- Date Received
- December 20, 1993
- Decision Date
- January 26, 1994
- Product Code
- JEQ
- 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 |
|---|---|---|---|
| JEQ | Toothbrush, Powered | FDA class 1 | Dental |
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