Cleared Traditional

K160102 - Amber Mill Series and Amber Press Series

K160102 is an FDA 510(k) clearance for Amber Mill Series and Amber Press Series, manufactured by Hass Corp.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K160102 · Hass Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
177d
Days
Class 2
Risk

K160102 is an FDA 510(k) clearance for the Amber Mill Series and Amber Press Series. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Hass Corp. (Gangneung-Si, KR). The FDA issued a Cleared decision on July 14, 2016 after a review of 177 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 Hass Corp. devices

FDA 510(k) Submission Details - K160102

510(k) Number K160102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2016
Decision Date July 14, 2016
Days to Decision 177 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
49d slower than avg
Panel avg: 128d · This submission: 177d
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

LK Consulting Group USA, Inc.
PRISCILLA CHUNG

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
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