Name: Predicase
Price: 199 USD

K-number	K232233
Device name	Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
Applicant	Align Technology, Inc.
Product code	NXC
Device class	Class II
Decision date	Sep 26, 2023
Decision	Substantially Equivalent
Regulation	872.5470

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Source

View the full FDA submission: accessdata.fda.gov

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Invisalign System with Mandibular Advancement Featuring Occlusal Blocks

Everything you need for a 510(k) submission. Nothing you don't.