Cleared Traditional

MIS LYNX Conical Connection Implant System

K251297 · Dentsply Sirona, Inc. · Dental
Jul 2025
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K251297 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 July 24, 2025, 87 days after receiving the submission on April 28, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K251297 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2025
Decision Date July 24, 2025
Days to Decision 87 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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