Cleared Traditional

K222367 - SAVE GBR

K222367 is the FDA 510(k) clearance for SAVE GBR by Dentis Co., Ltd.. It is a Class 2 Dental device (product code DZL) cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K222367 · Dentis Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
230d
Days
Class 2
Risk

K222367 is an FDA 510(k) clearance for the SAVE GBR. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Dentis Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on March 23, 2023 after a review of 230 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - 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 Dentis Co., Ltd. devices

Submission Details

510(k) Number K222367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2022
Decision Date March 23, 2023
Days to Decision 230 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 127d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZL Screw, Fixation, Intraosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4880
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 Consultant

Withus Group, Inc.
April Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZL Screw, Fixation, Intraosseous

All 41
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K222367.
MP Pin flat without thread (36BMP000020/MP20)
K240321 · Hager& Meisinger GmbH · Oct 2024
KLS Martin Drill-Free MMF Screw
K233721 · KLS-Martin L.P. · Sep 2024
Stryker MP, Mandible, HMMF and MMF AXS Screws
K231599 · Stryker Leibinger GmbH & Co KG · Aug 2023
The Micro Screw System, Micro Screw System Basic
K201210 · Hager& Meisinger GmbH · Oct 2021
Membrane Screws and Membrane Tacks
K201561 · Neoss Limited · Oct 2020
Bone Screw, Bone Tack
K182881 · Osstem Implant Co., Ltd. · Aug 2019