Cleared Traditional

K203351 - Perfit ZR HT Dental Zirconia blank

K203351 is an FDA 510(k) clearance for Perfit ZR HT Dental Zirconia blank, manufactured by Vatech Acucera, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K203351 · Vatech Acucera, Inc. · Dental device
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Mar 2021
Decision
115d
Days
Class 2
Risk

K203351 is an FDA 510(k) clearance for the Perfit ZR HT Dental Zirconia blank. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Vatech Acucera, Inc. (Yongin-Si, KR). The FDA issued a Cleared decision on March 8, 2021 after a review of 115 days - within the typical 510(k) review window.

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 Vatech Acucera, Inc. devices

FDA 510(k) Submission Details - K203351

510(k) Number K203351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2020
Decision Date March 08, 2021
Days to Decision 115 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
12d faster than avg
Panel avg: 127d · This submission: 115d
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 285
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K203351.
Perfit FS Dental Zirconia Fully Sintered Block
K203590 · Vatech Acucera, Inc. · Jun 2021
Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank
K203499 · Vatech Acucera, Inc. · Apr 2021
Non-Sterile Zirconia Block
K201492 · Bioden Co., Ltd. · Mar 2021
GenesisZr 4Y+ (ST1100) Zirconia
K201915 · United Dental Resources Corporation · Feb 2021
GenesisZr UHT700 Zirconia
K201608 · United Dental Resources Corporation · Jan 2021
Dentsply Sirona Universal Spray Glazes
K202629 · Dentsply Sirona · Jan 2021