FDA applicant

Macrochem Corp.

Billerica, MA5 decisions1986–19890 recalls

FDA records 5 decisions for Macrochem Corp. (Billerica, MA) from 1986 to 1989: 5 510(k) clearances. Most are in product codes EMA (Cement, Dental) and DYH (Adhesive, Bracket And Tooth Conditioner, Resin). 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 Macrochem Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Macrochem Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Macrochem Corp.

Which product codes does it file in?

What has FDA decided for it lately?