Cleared Traditional

MIS Dental Implant System

K192149 · Dentsply Sirona, Inc. · Dental
Dec 2019
Decision
124d
Days
Class 2
Risk

About This 510(k) Submission

K192149 is an FDA 510(k) clearance for the MIS Dental 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 December 11, 2019, 124 days after receiving the submission on August 9, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K192149 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2019
Decision Date December 11, 2019
Days to Decision 124 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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