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510(k) K223496

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

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 26, 2023
Date Received: November 21, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Abutment, Implant, Dental, Endosseous
Device Class: Class II
Regulation Number: 872.3630
Review Panel: DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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