Cleared Traditional

2014 InterActive/SwishActive System

K143011 · Implant Direct Sybron Manufacturing, LLC · Dental
Jul 2015
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K143011 is an FDA 510(k) clearance for the 2014 InterActive/SwishActive System, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Implant Direct Sybron Manufacturing, LLC (Thousand Oaks, US). The FDA issued a Cleared decision on July 16, 2015, 269 days after receiving the submission on October 20, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K143011 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

Similar Devices — DZE Implant, Endosseous, Root-form

All 1539
Straumann? BLC Implants - Indication Widening
K252168 · Institut Straumann AG · Mar 2026
Dentis SQ-SL AXEL Fixture
K253493 · Dentis Co., Ltd. · Mar 2026
Nobel Biocare S Series Implants
K252197 · Nobel Biocare AB · Feb 2026
BIORES Dental Implant System
K252286 · Chengdu Besmile Medical Technology Co., Ltd. · Feb 2026
ZENEX Implant System_R-System
K252585 · Izenimplant Co., Ltd. · Jan 2026
GEN5? and GEN5+? 3.3mmD Dental Implants
K252145 · Paragon Implant Mfg., LLC · Dec 2025