Cleared Traditional

INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM

K130572 · Implant Direct Sybron Manufacturing, LLC · Dental
Dec 2013
Decision
295d
Days
Class 2
Risk

About This 510(k) Submission

K130572 is an FDA 510(k) clearance for the INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Implant Direct Sybron Manufacturing, LLC (Calabasas, US). The FDA issued a Cleared decision on December 24, 2013, 295 days after receiving the submission on March 4, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K130572 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2013
Decision Date December 24, 2013
Days to Decision 295 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