Cleared Traditional

K193078 - MIS CONNECT Conical Connection System

K193078 is the FDA 510(k) clearance for MIS CONNECT Conical Connection System by Dentsply Sirona. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K193078 · Dentsply Sirona · Dental device
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Mar 2020
Decision
141d
Days
Class 2
Risk

K193078 is an FDA 510(k) clearance for the MIS CONNECT Conical Connection System. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on March 25, 2020 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 K193078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2019
Decision Date March 25, 2020
Days to Decision 141 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
14d slower than avg
Panel avg: 127d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K193078.
Panthera Dental Milled Bars
K192108 · Panthera Dental, Inc. · Apr 2020
Straumann Screw-Retained Abutments
K192401 · Straumann USA, LLC · Apr 2020
Universal Base Conical Connection (CC)
K200040 · Nobel Biocare AG · Mar 2020
Sherlock
K193335 · Open Implants, LLC · Mar 2020
Pre-Milled Blank
K193425 · Arum Dentistry Co., Ltd. · Mar 2020
ATLANTIS Abutment for MIS Conical Connection Implants
K193529 · Dentsply Sirona · Mar 2020