Cleared Traditional

Implant Direct Dental Implant Systems Portfolio - MR Conditional (K222211) - FDA 510(k) Clearance

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

K222211 · Implant Direct Sybron Manufacturing, LLC · Dental device
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Feb 2023
Decision
192d
Days
Class 2
Risk

K222211 is an FDA 510(k) clearance for the Implant Direct Dental Implant Systems Portfolio - MR Conditional. 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 February 2, 2023 after a review of 192 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

Submission Details

510(k) Number K222211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2022
Decision Date February 02, 2023
Days to Decision 192 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 127d · This submission: 192d
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 304
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K222211.
Genesis ACTIVE Implant System
K223814 · Keystone Dental, Inc. · May 2023
Point implant system
K222738 · Pointnix Co., Ltd. · Apr 2023
Provata Implant System
K222457 · Southern Implants (Pty), Ltd. · Mar 2023
S-Mono
K221317 · Shinhung Mst Co., Ltd. · Jan 2023
BLUEDIAMOND IMPLANT, Abutment Screw
K211812 · Megagen Implant Co., Ltd. · Jan 2023
Bonafix 2 Plus
K213677 · Zentek Medical, LLC · Dec 2022