510(k) K241692

MIS LYNX Conical Connection Implant System by Dentsply Sirona, Inc. — Product Code DZE

K241692 is an FDA 510(k) premarket notification submitted by Dentsply Sirona, Inc. for the device "MIS LYNX Conical Connection Implant System". The FDA issued a decision of Substantially Equivalent on Nov 25, 2024. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Dentsply Sirona, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 25, 2024
Date Received
Jun 12, 2024
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