510(k) Report

FDA applicant

Biomate Medical Devices Technology Co., Ltd.

Kaohsiung County, TW3 decisions2011–20180 recalls

FDA records 3 decisions for Biomate Medical Devices Technology Co., Ltd. (Kaohsiung County, TW) from 2011 to 2018: 3 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and MQX (Needle, Acupuncture, Single Use). Its devices cite 3 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 Biomate Medical Devices Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2011: 12015: 12018: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Biomate Medical Devices Technology Co., Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form2decisions
  • MQXNeedle, Acupuncture, Single Use1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142174Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd. · 20151cites it

What has FDA decided for it lately?

  • K170732Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd. · 2018
  • K142174Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd. · 2015
  • K103061Biomate Sterile Acupuncture NeedleBiomate Medical Devices Technology Co., Ltd. · 2011

All 3 as Biomate Medical Devices Technology Co., Ltd. →