510(k) K213139
K213139 is an FDA 510(k) premarket notification submitted by Kavo Dental GmbH for the device "SURGmatic S15 L Pro". The FDA issued a decision of Substantially Equivalent on December 21, 2021. The device falls under product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), a Class I device regulated under 21 CFR 872.4200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2021
- Date Received
- September 27, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Contra- And Right-Angle Attachment, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type