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FDA 510(k)

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

K-Number: K223496 · 2023-09-26

ApplicantPrismatik Dentalcraft, Inc.
Decision Date2023-09-26
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2023-09-26 under approval number K223496. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems is a medical device that received FDA 510(k) clearance on 2023-09-26. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K223496.

When was Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems approved by the FDA?

Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems received FDA 510(k) clearance on 2023-09-26, under approval number K223496.

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

Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems is manufactured by Prismatik Dentalcraft, Inc..

What is the FDA product code for Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems?

The FDA product code for Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems is NHA.

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Related PubMed Literature

PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026)

Other Devices by Prismatik Dentalcraft, Inc.

K162537CAD/CAMouflage Milling Block K160979Inclusive Abutments K160425CAD/CAMouflage Milling Bock K153099INCLUSIVE TAPERED IMPLANT SYSTEM K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System K191903BruxZir GT (Gum Tissue) Color

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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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