Cleared Traditional

K172505 - MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments

K172505 is an FDA 510(k) clearance for MIS C1 Narrow Platform Conical Connecti..., manufactured by Mis Implants Technologies , Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K172505 · Mis Implants Technologies , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Mis Implants Technologies , Ltd. devices

FDA 510(k) Submission Details - K172505

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 127d · This submission: 132d
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 Consultant

Hogan Lovells US LLP
Randy Prebula

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1184
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K172505.
AR_N Type Implant System
K171297 · Biotem Co., Ltd. · Jan 2018
SPI Dental Implant System
K172240 · Msi France · Jan 2018
Straumann Dental Implant System
K171784 · Straumann USA, LLC · Jan 2018
PREMIUM ONE Implant Systems
K172560 · Sweden & Martina S.P.A. · Dec 2017
S.I.N. Implant System
K170392 · S.I.N. ? Sistema DE Implante Nacional S.A. · Dec 2017
IR Type Implant System
K171185 · Biotem Co., Ltd. · Dec 2017