FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
EndoPilot2
K Number: K202906
·
Decision Apr 13, 2021
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
191
Applicant Total
1
Review Days
196
Basic Information
- Device Name
- EndoPilot2
- K Number
- K202906
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Schlumbohm GmbH & Co. KG
- Date Received
- September 29, 2020
- Decision Date
- April 13, 2021
- Product Code
- ELC
- 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 |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | FDA class 2 | Dental |
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