510(k) Report

FDA applicant

T-Plus Implant Tech. Co., Ltd.

New Taipei County, TW4 decisions2013–20200 recalls

FDA records 4 decisions for T-Plus Implant Tech. Co., Ltd. (New Taipei County, TW) from 2013 to 2020: 4 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Since 2016 its 510(k)s took a median of 301 days from receipt to decision, against 219 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 2 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 T-Plus Implant Tech. Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2013: 12016: 22020: 1
2013high 2 (2016) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — T-Plus Implant Tech. Co., Ltd. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like T-Plus Implant Tech. Co., Ltd.’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?

  • DZEImplant, Endosseous, Root-Form4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 301 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 219 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K152787ST Internal Fixture SystemT-Plus Implant Tech. Co., Ltd. · 20162cite it
  • K132992TI Star Implant SystemT-Plus Implant Tech. Co., Ltd. · 20131cites it

What has FDA decided for it lately?

  • K190919ST Internal Implant SystemT-Plus Implant Tech. Co., Ltd. · 2020
  • K152787ST Internal Fixture SystemT-Plus Implant Tech. Co., Ltd. · 2016
  • K152786A Plus Internal Fixture SystemT-Plus Implant Tech. Co., Ltd. · 2016
  • K132992TI Star Implant SystemT-Plus Implant Tech. Co., Ltd. · 2013

All 4 as T-Plus Implant Tech. Co., Ltd. →