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FDA 510(k)

Invisalign Specifix Attachment System

K-Number: K252870 · 2025-10-09

ApplicantAlign Technology, Inc.
Decision Date2025-10-09
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Invisalign Specifix Attachment System is a medical device manufactured by Align Technology, Inc.. It received FDA 510(k) clearance on 2025-10-09 under approval number K252870. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Invisalign Specifix Attachment System?

Invisalign Specifix Attachment System is a medical device that received FDA 510(k) clearance on 2025-10-09. It is manufactured by Align Technology, Inc.. The 510(k) number is K252870.

When was Invisalign Specifix Attachment System approved by the FDA?

Invisalign Specifix Attachment System received FDA 510(k) clearance on 2025-10-09, under approval number K252870.

What company makes Invisalign Specifix Attachment System?

Invisalign Specifix Attachment System is manufactured by Align Technology, Inc..

What is the FDA product code for Invisalign Specifix Attachment System?

The FDA product code for Invisalign Specifix Attachment System is NXC.

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Other Devices by Align Technology, Inc.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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