Cleared Traditional

K143011 - 2014 InterActive/SwishActive System

K143011 is an FDA 510(k) clearance for 2014 InterActive/SwishActive System, manufactured by Implant Direct Sybron Manufacturing, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K143011 · Implant Direct Sybron Manufacturing, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
269d
Days
Class 2
Risk

K143011 is an FDA 510(k) clearance for the 2014 InterActive/SwishActive System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Direct Sybron Manufacturing, LLC (Thousand Oaks, US). The FDA issued a Cleared decision on July 16, 2015 after a review of 269 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 Implant Direct Sybron Manufacturing, LLC devices

FDA 510(k) Submission Details - K143011

510(k) Number K143011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2014
Decision Date July 16, 2015
Days to Decision 269 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 127d · This submission: 269d
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 759
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K143011.
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NobelActive
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Hahn Tapered Implant System
K143353 · Prismatik Dentalcraft, Inc. · Apr 2015
BioHorizons Tapered Internal Implants
K143022 · BioHorizons Implant Systems, Inc. · Jan 2015