Cleared Traditional

K203590 - Perfit FS Dental Zirconia Fully Sintere...

K203590 is an FDA 510(k) clearance for Perfit FS Dental Zirconia Fully Sintere..., 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 198-day FDA review.

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

FDA 510(k) Submission Details - K203590

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.

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 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