510(k) K220346
K220346 is an FDA 510(k) premarket notification submitted by Ajk Engineering, Inc. for the device "Lotus Prophy Angle". The FDA issued a decision of Substantially Equivalent on November 7, 2022. 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
- November 7, 2022
- Date Received
- February 7, 2022
- 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