FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONDYLAFORM II NFC
K Number: K060565
·
Decision May 8, 2006
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
54
Applicant Total
65
Review Days
66
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Basic Information
- Device Name
- CONDYLAFORM II NFC
- K Number
- K060565
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3590
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ivoclar Vivadent, Inc.
- Date Received
- March 3, 2006
- Decision Date
- May 8, 2006
- Product Code
- ELM
- 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 |
|---|---|---|---|
| ELM | Denture, Plastic, Teeth | FDA class 2 | Dental |
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