Cleared Traditional

K160367 - Nissin Dental Zirconia Blank & Dental Z...

K160367 is an FDA 510(k) clearance for Nissin Dental Zirconia Blank & Dental Z..., manufactured by Nissin-Metec China Co., Ltd.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K160367 · Nissin-Metec China Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
169d
Days
Class 2
Risk

K160367 is an FDA 510(k) clearance for the Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Nissin-Metec China Co., Ltd. (Kunshan, CN). The FDA issued a Cleared decision on July 27, 2016 after a review of 169 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 Nissin-Metec China Co., Ltd. devices

FDA 510(k) Submission Details - K160367

510(k) Number K160367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2016
Decision Date July 27, 2016
Days to Decision 169 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
42d slower than avg
Panel avg: 127d · This submission: 169d
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 Peers - EIH Powder, Porcelain

All 291
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K160367.
n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,
K160262 · Institut Straumann AG · Sep 2016
Initial LiSi Block
K153130 · GC America, Inc. · Sep 2016
CELTRA Press
K161269 · Dentsply Sirona · Aug 2016
rainbow LS Block
K160144 · Genoss Co., Ltd. · Jul 2016
Initial LiSi Press
K153136 · GC America, Inc. · Jun 2016
CEREC SpeedGlaze
K160099 · Sirona Dental Systems GmbH · Jun 2016