FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPTI
K Number: K063646
·
Decision Mar 7, 2007
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- OPTI
- K Number
- K063646
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Camsight Co., Inc.
- Date Received
- December 7, 2006
- Decision Date
- March 7, 2007
- Product Code
- EIA
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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