Cleared Traditional

K172761 - New Century All-Ceramic Dental Zirconia...

K172761 is an FDA 510(k) clearance for New Century All-Ceramic Dental Zirconia..., manufactured by Shanghai New Century Dental Materials Co., Ltd.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K172761 · Shanghai New Century Dental Materials Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
65d
Days
Class 2
Risk

K172761 is an FDA 510(k) clearance for the New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded). Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Shanghai New Century Dental Materials Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on November 17, 2017 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shanghai New Century Dental Materials Co., Ltd. devices

FDA 510(k) Submission Details - K172761

510(k) Number K172761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2017
Decision Date November 17, 2017
Days to Decision 65 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
62d faster than avg
Panel avg: 127d · This submission: 65d
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 288
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K172761.
VITA YZ ST and VITA YZ XT
K180703 · Vita Zahnfabrik H.Rauter GmbH & Co. · Aug 2018
Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank
K180252 · Crown Porcelain Dental Technology Co., Ltd. · Apr 2018
DMAX Coloring Liquid
K173769 · Dmax Co., Ltd. · Mar 2018
n!ce for Planmill
K173410 · Institut Straumann AG · Nov 2017
CERABIEN ZR
K170834 · Kuraray Noritake Dental, Inc. · Oct 2017
KATANA Zirconia Block
K170986 · Kuraray Noritake Dental, Inc. · Jul 2017