Cleared Traditional

K151996 - TAURUS C1

K151996 is an FDA 510(k) clearance for TAURUS C1, manufactured by Shinhung Company, Ltd.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K151996 · Shinhung Company, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
186d
Days
Class 1
Risk

K151996 is an FDA 510(k) clearance for the TAURUS C1. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Shinhung Company, Ltd. (Seoul, KR). The FDA issued a Cleared decision on January 22, 2016 after a review of 186 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Shinhung Company, Ltd. devices

FDA 510(k) Submission Details - K151996

510(k) Number K151996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2015
Decision Date January 22, 2016
Days to Decision 186 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 127d · This submission: 186d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIA Unit, Operative Dental

All 72
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K151996.
Forest Dental Unit
K173608 · Forest Dental Products, Inc. · Aug 2018
P50 Series Dental Operative Unit and Accessories
K171872 · Pelton & Crane · Apr 2018
K3
K152830 · Osstem Implant Co., Ltd. · Apr 2017
TENEO Dental Treatment Unit and Accessories
K151045 · Sirona Dental Systems GmbH · Jul 2015
INTEGO Family and Accesories
K150909 · Sirona Dental Systems GmbH · Jul 2015
CS 1200
K112321 · Carestream Health, Inc. · Nov 2011