510(k) Report

FDA applicant

Digitek Dental Solutions Limited

Kowloon, Hong Kong, CN1 decision2015–20150 recalls

FDA records 1 decision for Digitek Dental Solutions Limited (Kowloon, Hong Kong, CN) in 2015: 1 510(k) clearance. All are in product code NHA (Abutment, Implant, Dental, Endosseous). Its devices cite 2 predicates, 0 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 Digitek Dental Solutions Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Digitek Dental Solutions Limited by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Digitek Dental Solutions Limited’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?

  • NHAAbutment, Implant, Dental, Endosseous1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited · 2015

The one decision as Digitek Dental Solutions Limited →