FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
E-Denture Pro
K Number: K203641
·
Decision Mar 30, 2021
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
329
Applicant Total
5
Review Days
106
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Basic Information
- Device Name
- E-Denture Pro
- K Number
- K203641
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Envisiontec GmbH
- Date Received
- December 14, 2020
- Decision Date
- March 30, 2021
- Product Code
- EBI
- 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | FDA class 2 | Dental |
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