MED610

STRATASYS LTD · Model MED610 1Kg · UDI-DI 07290018915219

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510(k) clearances

Adverse events

Recalls

Facilities

Description

MED610™ is a light-curable polymerizable material intended to fabricate, by additive manufacturing, parts used in the production of dental surgical guides; and indirect bonding trays. The indirect bonding trays produced are suitable for dental indications including orthodontic indirect bonding trays. MED610™ is intended exclusively for professional dental work. Users should independently verify the suitability of the material for their particular application and intended purpose. MED610™ is not intended for long term use (up to 24 hours only) within the oral cavity.

Recalls

Date	Firm	Reason
2026-06-08	Klowen Braces	A product error defect may cause incorrect bracket placement.

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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.