510(k) Report

FDA applicant

Vatech Acucera, Inc.

Yongin-Si, KR4 decisions2021–20220 recalls

FDA records 4 decisions for Vatech Acucera, Inc. (Yongin-Si, KR) from 2021 to 2022: 4 510(k) clearances. All are in product code EIH (Powder, Porcelain). Since 2016 its 510(k)s took a median of 122 days from receipt to decision, against 131 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Vatech Acucera, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2021: 32022: 1
2021high 3 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Vatech Acucera, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vatech Acucera, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EIHPowder, Porcelain4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 122 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 131 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203590Perfit FS Dental Zirconia Fully Sintered BlockVatech Acucera, Inc. · 20212cite it

What has FDA decided for it lately?

  • K222686Perfit FS Dental Zirconia Fully Sintered BlockVatech Acucera, Inc. · 2022
  • K203590Perfit FS Dental Zirconia Fully Sintered BlockVatech Acucera, Inc. · 2021
  • K203499Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blankVatech Acucera, Inc. · 2021
  • K203351Perfit ZR HT Dental Zirconia blankVatech Acucera, Inc. · 2021

All 4 as Vatech Acucera, Inc. →

Other applicant names beginning “Vatech”

FDA records each applicant name separately; these may or may not be the same firm.

VATECH Co., Ltd. 40Vatech Mcis Co., Ltd. 1Vatech Value Added Technology Co., Ltd. 1