Cleared Traditional

K233194 - TS Abutment System (FDA 510(k) Clearance)

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

K233194 · Osstem Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
145d
Days
Class 2
Risk

K233194 is an FDA 510(k) clearance for the TS Abutment System. 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 Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on February 20, 2024 after a review of 145 days - within the typical 510(k) review window.

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 Osstem Implant Co., Ltd. devices

Submission Details

510(k) Number K233194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2023
Decision Date February 20, 2024
Days to Decision 145 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
18d slower than avg
Panel avg: 127d · This submission: 145d
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

Hiossen, Inc.
Peter 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 701
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K233194.
DESS Dental Smart Solutions
K253804 · Terrats Medical SL · Apr 2026
LOCATOR® Angled Abutment
K260555 · Zest Anchors, LLC · Apr 2026
Healing Abutment System
K251434 · Osstem Implant Co., Ltd. · Mar 2026
Solidex® Ti-Links and Screws
K251515 · CreoDent Hudson Valley · Feb 2026
Multi-Unit DAS System
K243732 · Talladium Espa?a, SL · Jan 2026
EK MULTI ANGLED 30 ABUTMENT
K251427 · Hiossen, Inc. · Jan 2026