Cleared Traditional

K203499 - Perfit ZR ST Dental Zirconia blank

K203499 is an FDA 510(k) clearance for Perfit ZR ST 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 129-day FDA review.

K203499 · Vatech Acucera, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
129d
Days
Class 2
Risk

K203499 is an FDA 510(k) clearance for the Perfit ZR ST Dental Zirconia blank, Perfit ZR UT 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 April 5, 2021 after a review of 129 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 - K203499

510(k) Number K203499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2020
Decision Date April 05, 2021
Days to Decision 129 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
2d slower than avg
Panel avg: 127d · This submission: 129d
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 K203499.
Estar-Z
K210097 · Osstem Implant Co., Ltd. · Jul 2021
MAZIC Claro CAD and MAZIC Claro Press
K203672 · Vericom Co., Ltd. · Jul 2021
Perfit FS Dental Zirconia Fully Sintered Block
K203590 · Vatech Acucera, Inc. · Jun 2021
Non-Sterile Zirconia Block
K201492 · Bioden Co., Ltd. · Mar 2021
Perfit ZR HT Dental Zirconia blank
K203351 · Vatech Acucera, Inc. · Mar 2021
GenesisZr 4Y+ (ST1100) Zirconia
K201915 · United Dental Resources Corporation · Feb 2021