Cleared Traditional

K192221 - Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants (FDA 510(k) Clearance)

Also includes:
Legacy2, Legacy3, Legacy4 fixture-mounts

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192221 · Implant Direct Sybron Manufacturing, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
315d
Days
Class 2
Risk

K192221 is an FDA 510(k) clearance for the Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants. 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 June 25, 2020 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K192221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2019
Decision Date June 25, 2020
Days to Decision 315 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
188d slower than avg
Panel avg: 127d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 1541
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K192221.
Adin Long Dental Implant System
K252031 · Adin Dental Implant Systems , Ltd. · Mar 2026
ZENEX Implant System_Short (R-System)
K253334 · Izenimplant Co., Ltd. · Mar 2026
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