FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
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K Number: K150218
·
Decision Jun 23, 2015
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
16
Review Days
144
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Basic Information
- Device Name
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- K Number
- K150218
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Coltene/Whaledent AG
- Date Received
- January 30, 2015
- Decision Date
- June 23, 2015
- 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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