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Attachment Template

Align Technology, Inc. · Model 100012 · UDI-DI 00816063022169

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Invisalign™ Attachment Templates are disposable polyurethane accessory to Invisalign System and are intended to guide the placement of dental composite (material provided by doctor) to the tooth surface to create shapes known as attachments, which are used for aligner retention or optimized aligner force system for tooth movement. The configuration and types of attachments shapes are defined by the treatment plan.

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.