FDA applicant

Rolence Enteprise, Inc.

Chungi, TW2 decisions2004–20050 recalls

FDA records 2 decisions for Rolence Enteprise, Inc. (Chungi, TW) from 2004 to 2005: 2 510(k) clearances. Most are in product codes ELC (Scaler, Ultrasonic) and EIA (Unit, Operative Dental). 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 Rolence Enteprise, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rolence Enteprise, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Rolence”

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

Rolence Enterprise Co., Ltd. 14 Rolence Ent., Inc. 5

Rolence Enteprise, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Rolence”