FDA.reportPublic FDA data

510(k) K231097

Device
Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems
Applicant
Prismatik Dentalcraft, Inc.
510(k) number
K231097
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-14
Date received
2023-04-18
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 96212 96212

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NHA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K251434Healing Abutment SystemOsstem Implant Co., Ltd.2026-03-04
K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley2026-02-10
K251427EK MULTI ANGLED 30 ABUTMENTHiossen, Inc.2026-01-29
K243732Multi-Unit DAS SystemTalladium España, SL2026-01-29
K253315Straumann Variobase Abutments XC for Bridge/BarInstitut Straumann AG2026-01-22
K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.2026-01-22
K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.2026-01-07
K253341Custom Abutments ASMedentika GmbH2025-12-23
K253312OrangeCAD Med AbutmentsOrangecad Med GmbH2025-12-23
K252320SIMDA AbutmentsSimda Co., Ltd.2025-12-18