Cleared Traditional

Perfit ZR HT Dental Zirconia blank (K203351) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 184
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