FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLORISE
K Number: K070677
·
Decision May 11, 2007
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
19
Review Days
60
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Basic Information
- Device Name
- COLORISE
- K Number
- K070677
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Zhermack S.P.A.
- Date Received
- March 12, 2007
- Decision Date
- May 11, 2007
- 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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Other Clearances by Zhermack S.P.A.
| K Number | Device Name | ||
|---|---|---|---|
| K083739 | HYDRORISE AND HYDROSYSTEM | Mar 26, 2009 | Substantially Equivalent |
| K081084 | COLORISE RIGID | May 14, 2008 | Substantially Equivalent |
| K080130 | OCCLUFAST CAD | Mar 14, 2008 | Substantially Equivalent |
| K073005 | ELITE GLASS | Dec 12, 2007 | Substantially Equivalent |
| K070700 | FREEALGIN | Apr 25, 2007 | Substantially Equivalent |
| K053619 | COLORBITE | Mar 1, 2006 | Substantially Equivalent |
| K050417 | ELITE IMPLANT | Jul 19, 2005 | Substantially Equivalent |
| K051424 | HYDROGUM 5 | Jul 15, 2005 | Substantially Equivalent |
| K043118 | HYDROGUM SOFT | Jan 24, 2005 | Substantially Equivalent |
| K043131 | TORPICALGIN | Dec 15, 2004 | Substantially Equivalent |