Cleared Traditional

Perfit FS Dental Zirconia Fully Sintered Block (K203590) - FDA 510(k) Clearance

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

K203590 · Vatech Acucera, Inc. · Dental device
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Jun 2021
Decision
198d
Days
Class 2
Risk

K203590 is an FDA 510(k) clearance for the Perfit FS Dental Zirconia Fully Sintered Block. 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 June 24, 2021 after a review of 198 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 Vatech Acucera, Inc. devices

Submission Details

510(k) Number K203590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2020
Decision Date June 24, 2021
Days to Decision 198 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
71d slower than avg
Panel avg: 127d · This submission: 198d
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 K203590.
1Derful HS, 1Derful HT
K210884 · 1derful, Inc. · Jul 2021
Estar-Z
K210097 · Osstem Implant Co., Ltd. · Jul 2021
MAZIC Claro CAD and MAZIC Claro Press
K203672 · Vericom Co., Ltd. · Jul 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
Perfit ZR HT Dental Zirconia blank
K203351 · Vatech Acucera, Inc. · Mar 2021