Name: Predicase
Price: 199 USD

K-number	K223496
Device name	Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems
Applicant	Prismatik Dentalcraft, Inc.
Product code	NHA
Device class	Class II
Decision date	Sep 26, 2023
Decision	Substantially Equivalent
Regulation	872.3630

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Source

View the full FDA submission: accessdata.fda.gov

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Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems

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