510(k) K211556
K211556 is an FDA 510(k) premarket notification submitted by Megagen Implant Co., Ltd. for the device "N2". The FDA issued a decision of Substantially Equivalent on April 5, 2023. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Megagen Implant Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2023
- Date Received
- May 19, 2021
- 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