FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇷 Brazil
Opallis, Opallis Flow
K Number: K201707
·
Decision Dec 22, 2020
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
10
Review Days
183
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Basic Information
- Device Name
- Opallis, Opallis Flow
- K Number
- K201707
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentscare Ltda
- Date Received
- June 22, 2020
- Decision Date
- December 22, 2020
- 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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