FDA applicant

Rolence Enterprise Co., Ltd.

Chungli, Taiwan, TW14 decisions1993–20210 recalls

FDA records 14 decisions for Rolence Enterprise Co., Ltd. (Chungli, Taiwan, TW) from 1993 to 2021: 14 510(k) clearances. Most are in product codes EBZ (Activator, Ultraviolet, For Polymerization) and EBF (Material, Tooth Shade, Resin). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Rolence Enterprise, Inc.”.

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 Rolence Enterprise Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007high 1 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rolence Enterprise Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Rolence Enterprise Co., Ltd.’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

Other applicant names beginning “Rolence”

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

Rolence Ent., Inc. 5 Rolence Enteprise, Inc. 2

Rolence Enterprise Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Rolence”