Cleared Traditional

K182908 - Ziacom Dental Implant Systems

K182908 is the FDA 510(k) clearance for Ziacom Dental Implant Systems by Ziacom Medical, S.L.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K182908 · Ziacom Medical, S.L. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
274d
Days
Class 2
Risk

K182908 is an FDA 510(k) clearance for the Ziacom Dental Implant Systems. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Ziacom Medical, S.L. (Pinto, ES). The FDA issued a Cleared decision on July 18, 2019 after a review of 274 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 Ziacom Medical, S.L. devices

Submission Details

510(k) Number K182908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2018
Decision Date July 18, 2019
Days to Decision 274 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
147d slower than avg
Panel avg: 127d · This submission: 274d
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

Ziacom Medical Slu
Alvaro Idiago

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 K182908.
ALFA GATE Dental Implants System
K182143 · Alfa Gate Mazen, Ltd. · Oct 2019
SGS Dental Implants System
K182219 · Sgs International, Ltd. · Aug 2019
IS-III active System_S-narrow Type
K190849 · Neobiotech Co., Ltd. · Aug 2019
Zygomatic Implants
K190718 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Jul 2019
PRAMA White Implant Systems
K180365 · Sweden & Martina S.P.A. · Jul 2019
Surgikor Dental Implant System
K182615 · Surgikor, LLC · Jul 2019