FDA applicant

Oratec Dental Products

Mchenry, IL3 decisions1976–19760 recalls

FDA records 3 decisions for Oratec Dental Products (Mchenry, IL) in 1976: 3 510(k) clearances. Most are in product codes ELW (Material, Impression) and EMA (Cement, 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 Oratec Dental Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oratec Dental Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Oratec Dental Products’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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Other applicant names beginning “Oratec”

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

Oratec Interventions, Inc. 24 Oratec Corp. 1

Oratec Dental Products

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Oratec”