Cleared Traditional

Faico Dental Implant System (K192015) - FDA 510(k) Clearance

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

K192015 · Faico Medical, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
249d
Days
Class 2
Risk

K192015 is an FDA 510(k) clearance for the Faico Dental Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Faico Medical, LLC (Boca Raton, US). The FDA issued a Cleared decision on April 3, 2020 after a review of 249 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 Faico Medical, LLC devices

Submission Details

510(k) Number K192015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2019
Decision Date April 03, 2020
Days to Decision 249 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
122d slower than avg
Panel avg: 127d · This submission: 249d
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

Licensale, Inc.
Raymond Kelly

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 304
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K192015.
Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
K193592 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Apr 2020
Implantswiss Dental Implant System and Implantswiss Dental Abutment System
K200867 · Novodent SA · Apr 2020
s-Clean SQ-SL Implant System Mini
K200099 · Dentis Co., Ltd. · Apr 2020
DSI Dental Implant System
K200188 · Dsi Dental Solutions, Ltd. · Apr 2020
ST Internal Implant System
K190919 · T-Plus Implant Tech. Co., Ltd. · Feb 2020
AR_N SLA Type Implant System
K190641 · Biotem Co., Ltd. · Feb 2020