Cleared Traditional

K200102 - MIS Dental Implant System

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

K200102 · Dentsply Sirona · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K200102

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.

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 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