FDA applicant

Asahi Optical Co. C/O Rosati Associates, P.C.

Birmingham, MI4 decisions1986–19890 recalls

FDA records 4 decisions for Asahi Optical Co. C/O Rosati Associates, P.C. (Birmingham, MI) from 1986 to 1989: 4 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and HQG (Lens, Spectacle, Non-Custom (Prescription)). 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 Asahi Optical Co. C/O Rosati Associates, P.C.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Asahi Optical Co. C/O Rosati Associates, P.C. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Asahi Optical Co. C/O Rosati Associates, P.C. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Asahi Optical Co. C/O Rosati…’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 “Asahi”

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

Asahi Intecc Co., Ltd. 84 Asahi Medical Co., Ltd. 16 Asahi Kasei Medical Co., Ltd. 6 Asahi Polyslider Co., Ltd. 2 Asahi Intecc USA, Inc. 1 Asahi Iryoki Co., Ltd. 1 Asahi Kasei Pharma Corporation 1

Asahi Optical Co. C/O Rosati Associates, P.C.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Asahi”