FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IN-OVATION C
K Number: K060837
·
Decision Apr 10, 2006
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
59
Applicant Total
23
Review Days
13
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Basic Information
- Device Name
- IN-OVATION C
- K Number
- K060837
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentsply International
- Date Received
- March 28, 2006
- Decision Date
- April 10, 2006
- Product Code
- NJM
- 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 |
|---|---|---|---|
| NJM | Bracket, Ceramic, Orthodontic | FDA class 2 | Dental |
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| K050386 | PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM | Feb 23, 2005 | Substantially Equivalent |
| K041372 | SMARTLITE PS PEN-STYLE LED CURING LIGHT | Jun 24, 2004 | Substantially Equivalent |
| K041335 | PTM SYSTEM | Jun 16, 2004 | Substantially Equivalent |