FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Renamel NANO +plus
K Number: K163480
·
Decision Feb 24, 2017
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
28
Review Days
74
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Basic Information
- Device Name
- Renamel NANO +plus
- K Number
- K163480
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cosmedent, Inc.
- Date Received
- December 12, 2016
- Decision Date
- February 24, 2017
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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| K092730 | COSMEDENT BRUSHABLE COMPOSITE | Nov 20, 2009 | Substantially Equivalent |
| K070583 | NANO COMPOSITE | Apr 16, 2007 | Substantially Equivalent |
| K060881 | TEMPORARY CROWN & BRIDGE RESIN | May 16, 2006 | Substantially Equivalent |
| K052263 | MULTIPLE (TOOTH DESENSITIZER) | Dec 16, 2005 | Substantially Equivalent |
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