Cleared Traditional

K190641 - AR_N SLA Type Implant System

K190641 is an FDA 510(k) clearance for AR_N SLA Type Implant System, manufactured by Biotem Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K190641 · Biotem Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
345d
Days
Class 2
Risk

K190641 is an FDA 510(k) clearance for the AR_N SLA Type Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Biotem Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on February 21, 2020 after a review of 345 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 Biotem Co., Ltd. devices

FDA 510(k) Submission Details - K190641

510(k) Number K190641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2019
Decision Date February 21, 2020
Days to Decision 345 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
218d slower than avg
Panel avg: 127d · This submission: 345d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

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

Provision Consulting Group, Inc.
Joyce Bang-Kwun

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 766
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K190641.
Faico Dental Implant System
K192015 · Faico Medical, LLC · 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
SDS2.2 dental implant
K190406 · Sds Swiss Dental Solutions AG · Feb 2020
Implacil Implant System
K183024 · Implacil DE Bortoli Material Odontologico Ltda · Feb 2020
K3Pro Konus New Abutments and Implants
K190192 · Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG · Feb 2020