Cleared Traditional

K160670 - ET US SS Prosthetic system

K160670 is the FDA 510(k) clearance for ET US SS Prosthetic system by Osstem Implant Co., Ltd.. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 411-day FDA review.

K160670 · Osstem Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
411d
Days
Class 2
Risk

K160670 is an FDA 510(k) clearance for the ET US SS Prosthetic 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 April 25, 2017 after a review of 411 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Osstem Implant Co., Ltd. devices

Submission Details

510(k) Number K160670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2016
Decision Date April 25, 2017
Days to Decision 411 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
284d slower than avg
Panel avg: 127d · This submission: 411d
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.
DAVID KIM

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 387
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K160670.
Straumann Variobase Abutments
K170354 · Institut Straumann AG · Jun 2017
Straumann Variobase Abutments
K170356 · Institut Straumann AG · Jun 2017
OSSTEM Implant System - Abutment
K161689 · Osstem Implant Co., Ltd. · May 2017
Multibase Abutments EV and ATLANTIS Suprastructures
K163350 · Dentsply Sirona · Mar 2017
Multi-unit Abutment Plus
K161416 · Nobel Biocare AB · Mar 2017
On1 Concept
K161655 · Nobel Biocare AB · Feb 2017