510(k) K202046
K202046 is an FDA 510(k) premarket notification submitted by Kj Meditech Co., Ltd. for the device "LOTA SLA Dental Implant System and LOTA HA Dental Implant System". The FDA issued a decision of Substantially Equivalent on Mar 1, 2022. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Kj Meditech Co., Ltd. has 11 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 1, 2022
- Date Received
- Jul 23, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type
- 510(k)