FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
IMPRESSIX, COLORCHANGE ALGINATE
K Number: K062400
·
Decision Nov 16, 2006
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
26
Review Days
92
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Basic Information
- Device Name
- IMPRESSIX, COLORCHANGE ALGINATE
- K Number
- K062400
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cavex Holland BV
- Date Received
- August 16, 2006
- Decision Date
- November 16, 2006
- 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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|---|---|---|---|
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| K072245 | EMULATE ADVANCED | Nov 8, 2007 | Substantially Equivalent |
| K061267 | SIMULATE, COLOR CHANGE ALGINATE | Jul 10, 2006 | Substantially Equivalent |
| K052455 | IMPRESSIX | Nov 23, 2005 | Substantially Equivalent |
| K051207 | CAVEX ORTHOTRACE | Jun 21, 2005 | Substantially Equivalent |
| K042806 | QUADRANT UNIT-1-BOND | Nov 24, 2004 | Substantially Equivalent |
| K032116 | TULIP COLORSWITCH | Sep 30, 2003 | Substantially Equivalent |
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