FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLINI-DENT
K Number: K000140
·
Decision May 3, 2000
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
1
Applicant Total
1
Review Days
106
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Basic Information
- Device Name
- CLINI-DENT
- K Number
- K000140
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6855
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Precident Group
- Date Received
- January 18, 2000
- Decision Date
- May 3, 2000
- Product Code
- MAU
- 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 |
|---|---|---|---|
| MAU | Eraser, Dental Stain | FDA class 1 | Dental |
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