Cleared Traditional

K200102 - MIS Dental Implant System

K200102 is the FDA 510(k) clearance for MIS Dental Implant System by Dentsply Sirona. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K200102 · Dentsply Sirona · Dental device
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Sep 2020
Decision
230d
Days
Class 2
Risk

K200102 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 (York, US). The FDA issued a Cleared decision on September 3, 2020 after a review of 230 days - an extended review cycle.

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 devices

Submission Details

510(k) Number K200102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2020
Decision Date September 03, 2020
Days to Decision 230 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
103d slower than avg
Panel avg: 127d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K200102.
Honorst Implant System
K202039 · Medimecca Co., Ltd. · Sep 2020
IBS Implant System
K202479 · Innobiosurg Co., Ltd. · Sep 2020
Neodent Implant System - GM Helix Implants 7.0
K201225 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Sep 2020
Nucleoss T6 Dental Implant System
K192062 · Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST · Aug 2020
Magicore System
K201981 · Innobiosurg Co., Ltd. · Aug 2020
Straumann TLX Implant System
K200586 · Institut Straumann AG · Aug 2020