Cleared Traditional

K182219 - SGS Dental Implants System

K182219 is the FDA 510(k) clearance for SGS Dental Implants System by Sgs International, Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K182219 · Sgs International, Ltd. · Dental device
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Aug 2019
Decision
379d
Days
Class 2
Risk

K182219 is an FDA 510(k) clearance for the SGS Dental Implants System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sgs International, Ltd. (Budapest, HU). The FDA issued a Cleared decision on August 29, 2019 after a review of 379 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 Sgs International, Ltd. devices

Submission Details

510(k) Number K182219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2018
Decision Date August 29, 2019
Days to Decision 379 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
252d slower than avg
Panel avg: 127d · This submission: 379d
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 Consultant

Sterling Medical Registration
Daniela Levy

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 - DZE Implant, Endosseous, Root-form

All 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K182219.
AnyRidge Octa 1 Implant System
K182448 · Megagen Implant Co., Ltd. · Oct 2019
Advanced Intermezzo Implant System
K191127 · Megagen Implant Co., Ltd. · Oct 2019
ALFA GATE Dental Implants System
K182143 · Alfa Gate Mazen, Ltd. · Oct 2019
IS-III active System_S-narrow Type
K190849 · Neobiotech Co., Ltd. · Aug 2019
Ziacom Dental Implant Systems
K182908 · Ziacom Medical, S.L. · Jul 2019
Zygomatic Implants
K190718 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Jul 2019