FDA.reportPublic FDA data

510(k) K132844

Device
STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES
Applicant
STRAUMANN USA, LLC
510(k) number
K132844
Product code
NHA  
Decision
Substantially Equivalent (SESE)
Decision date
2014-01-15
Date received
2013-09-11
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
CHRISTOPHER KLACZYK
Address
60 Minuteman Rd. Andover MA US 01810 01810

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

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases