510(k) K202963
K202963 is an FDA 510(k) premarket notification submitted by Mgnewton , Ltd. for the device "ELEC Master, ELEC Master Dual". The FDA issued a decision of Substantially Equivalent on May 5, 2023. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Mgnewton , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 2023
- Date Received
- September 30, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type