FDA 510(k)

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks

K-번호: K232233 · 2023-09-26

결정일2023-09-26

제품 코드NXC

자문 위원회DE

결정Substantially Equivalent

기기 요약

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is the device name listed in this FDA 510(k) record. The listed applicant is Align Technology, Inc.. It received FDA 510(k) clearance on 2023-09-26 under 510(k) number K232233. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Invisalign System with Mandibular Advancement Featuring Occlusal Blocks?

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is a medical device that received FDA 510(k) clearance on 2023-09-26. The listed applicant is Align Technology, Inc.. The 510(k) number is K232233.

When did Invisalign System with Mandibular Advancement Featuring Occlusal Blocks receive FDA 510(k) clearance?

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks received FDA 510(k) clearance on 2023-09-26, under 510(k) number K232233.

Who is the listed applicant for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks?

The FDA 510(k) record lists Align Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks?

The FDA product code for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is NXC.

Align Technology, Inc.를 신청인으로 등재한 기타 기록

K262196Invisalign System K252931Invisalign® Palatal Expander System K252870Invisalign Specifix Attachment System K252380Invisalign System K241412Invisalign System K232887Invisalign Palatal Expander System

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