Cleared Traditional

SAVE GBR (K222451) - FDA 510(k) Clearance

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

K222451 · Dentis Co., Ltd. · Dental device
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Feb 2023
Decision
176d
Days
Class 2
Risk

K222451 is an FDA 510(k) clearance for the SAVE GBR. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Dentis Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on February 7, 2023 after a review of 176 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 K222451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2022
Decision Date February 07, 2023
Days to Decision 176 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
49d slower than avg
Panel avg: 127d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 318
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K222451.
Implant-One Multi-Unit Abutment
K212394 · Implant Logistics, Inc. · Mar 2023
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DESS Dental Smart Solutions
K221301 · Terrats Medical SL · Mar 2023
Luna Dental Implant System
K223395 · Shinhung Mst Co., Ltd. · Feb 2023
s-Clean Link Abutment
K222913 · Dentis Co., Ltd. · Jan 2023
MU System
K222976 · Dentis Co., Ltd. · Jan 2023