Cleared Traditional

K192149 - MIS Dental Implant System

K192149 is an FDA 510(k) clearance for MIS Dental Implant System, manufactured by Dentsply Sirona, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K192149 · Dentsply Sirona, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
124d
Days
Class 2
Risk

K192149 is an FDA 510(k) clearance for the MIS Dental Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on December 11, 2019 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentsply Sirona, Inc. devices

FDA 510(k) Submission Details - K192149

510(k) Number K192149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 127d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1182
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K192149.
Z5-BL
K190243 · Z-Systems AG · Jan 2020
Straumann BLX Ø3.5 mm Implants
K191256 · Institut Straumann AG · Dec 2019
EM Provisional
K191751 · Hiossen, Inc. · Dec 2019
Southern Implants MAX Implant System
K191054 · Southern Implants (Pty), Ltd. · Dec 2019
Straumann Mini Implants
K191895 · Institut Straumann AG · Dec 2019
JJ Implant System
K190552 · Jj Implants · Dec 2019