K223496

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

510(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. CA · US
Product code
NHA — Abutment, Implant, Dental, Endosseous
Decision date
2023-09-26
Date received
2022-11-21
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Dental
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain

Also available from FDA: K223496.pdf

Official FDA record: K223496
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.