Cleared Special

Perfit FS Dental Zirconia Fully Sintered Block (K222686) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K222686 · Vatech Acucera, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
30d
Days
Class 2
Risk

K222686 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 October 6, 2022 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vatech Acucera, Inc. devices

Submission Details

510(k) Number K222686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2022
Decision Date October 06, 2022
Days to Decision 30 days
Submission Type Special
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
97d faster than avg
Panel avg: 127d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K222686.
ICE Ceramics, ICE Stains, Fresco
K213722 · Zirkonzahn Srl · Dec 2022
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K222626 · Aidite (Qinhuangdao) Technology Co., Ltd. · Dec 2022
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K220816 · Prismatik Dentalcraft, Inc. · Aug 2022
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K221242 · Hunan Vsmile Biotechnology Co., Ltd. · Jul 2022