Cleared Traditional

K160144 - rainbow LS Block

K160144 is an FDA 510(k) clearance for rainbow LS Block, manufactured by Genoss Co., Ltd.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K160144 · Genoss Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
182d
Days
Class 2
Risk

K160144 is an FDA 510(k) clearance for the rainbow LS Block. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Genoss Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on July 21, 2016 after a review of 182 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 Genoss Co., Ltd. devices

FDA 510(k) Submission Details - K160144

510(k) Number K160144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2016
Decision Date July 21, 2016
Days to Decision 182 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
54d slower than avg
Panel avg: 128d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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

Ict America, Inc.
KIM BYUNGSUN

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 - EIH Powder, Porcelain

All 464
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K160144.
XP202
K161922 · 3M Deutschland GmbH · Sep 2016
CELTRA Press
K161269 · Dentsply Sirona · Aug 2016
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K160367 · Nissin-Metec China Co., Ltd. · Jul 2016
Amber Mill Series and Amber Press Series
K160102 · Hass Corp. · Jul 2016
Initial LiSi Press
K153136 · GC America, Inc. · Jun 2016
CEREC SpeedGlaze
K160099 · Sirona Dental Systems GmbH · Jun 2016