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Heron IOS

3D IMAGING AND SIMULATION CORP. AMERICAS · Model IOS-FP-71-001 · UDI-DI 00864206000406

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510(k) clearances

Adverse events

Recalls

148

Facilities

Description

Heron IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Heron IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.

Recalls

Date	Firm	Reason
2021-02-15	CARESTREAM DENTAL, LLC	The mirror may become detached and fall from the unit

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.