FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEREC 2 CROWN SOFTWARE
K Number: K972276
·
Decision Aug 15, 1997
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
15
Review Days
58
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Basic Information
- Device Name
- CEREC 2 CROWN SOFTWARE
- K Number
- K972276
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Siemens AG
- Date Received
- June 18, 1997
- Decision Date
- August 15, 1997
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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