Cleared Traditional

K151599 - iSy Implant System

K151599 is an FDA 510(k) clearance for iSy Implant System, manufactured by Altatec GmbH. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K151599 · Altatec GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
112d
Days
Class 2
Risk

K151599 is an FDA 510(k) clearance for the iSy Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Altatec GmbH (Wimsheim, DE). The FDA issued a Cleared decision on October 2, 2015 after a review of 112 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 Altatec GmbH devices

FDA 510(k) Submission Details - K151599

510(k) Number K151599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2015
Decision Date October 02, 2015
Days to Decision 112 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
15d faster than avg
Panel avg: 127d · This submission: 112d
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

PaxMed International, LLC
Linda Schulz

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 K151599.
Dental Implant System
K150388 · Bio Concept Co., Ltd. · Nov 2015
JDENTALCARE Implant System
K143142 · Jdentalcare Srl · Nov 2015
PUR Dental Implant System
K151928 · Sterngold Dental, LLC · Nov 2015
Anker Dental Implant System - SB-III, ST and AT series
K142557 · Alliance Global Technology Co., Ltd. · Sep 2015
Dental Implant OKTAGON Bone Level
K143539 · Hager& Meisinger GmbH · Aug 2015
Implanova
K150040 · Dental Evolutions, Inc. · Aug 2015