FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CS 1200
K Number: K112321
·
Decision Nov 10, 2011
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
48
Review Days
90
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Basic Information
- Device Name
- CS 1200
- K Number
- K112321
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carestream Health, Inc.
- Date Received
- August 12, 2011
- Decision Date
- November 10, 2011
- 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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