Cleared Traditional

MIS LYNX Conical Connection Implant System

K241692 · Dentsply Sirona, Inc. · Dental
Nov 2024
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K241692 is an FDA 510(k) clearance for the MIS LYNX Conical Connection Implant System, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on November 25, 2024, 166 days after receiving the submission on June 12, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K241692 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2024
Decision Date November 25, 2024
Days to Decision 166 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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