Cleared Traditional

K222211 - Implant Direct Dental Implant Systems P...

K222211 is an FDA 510(k) clearance for Implant Direct Dental Implant Systems P..., 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 192-day FDA review.

K222211 · Implant Direct Sybron Manufacturing, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K222211

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.

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 758
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