FDA.reportPublic FDA data

510(k) K223496

Device
Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems
Applicant
Prismatik Dentalcraft, Inc.
510(k) number
K223496
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-26
Date received
2022-11-21
Regulation
872.3630
Classification name
Abutment, Implant, Dental, Endosseous
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
So Hyun Park
Address
2144 Michelson Dr. Irvine CA US 92612 92612

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K261122MIST ICImagine Milling Technologies, LLC2026-06-27
K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.2026-06-26
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K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC2026-06-11
K260564DESS Dental Smart SolutionsTerrats Medical SL2026-06-09
K252904SIC Abutments including CAD/CAM SolutionsSic Invent AG2026-06-03
K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S2026-05-20
K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.2026-05-14
K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG2026-05-07
K253804DESS Dental Smart SolutionsTerrats Medical SL2026-04-16
K260555LOCATOR® Angled AbutmentZest Anchors, LLC2026-04-09