Cleared Traditional

K172505 - MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172505 · Mis Implants Technologies , Ltd. · Dental device
Dec 2017
Decision
132d
Days
Class 2
Risk

K172505 is an FDA 510(k) clearance for the MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platfor.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Mis Implants Technologies , Ltd. (Bar Lev Industrial Park, IL). The FDA issued a Cleared decision on December 28, 2017 after a review of 132 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.

Submission Details

510(k) Number K172505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2017
Decision Date December 28, 2017
Days to Decision 132 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 158d · This submission: 132d
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 69
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