FDA.reportPublic FDA data

510(k) K261327

Device
Elos Accurate Hybrid Base
Applicant
Elos Medtech Pinol A/S
510(k) number
K261327
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2026-09-30
Date received
2026-04-22
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
N

Applicant Contact#

Contact
Lise Terkelsen
Address
Engvej 33 Goerloese DK 3330 3330

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
K262207Cemented Plus AbutmentUnidental Co., Ltd.2026-09-23
K260940BellaTek BarsZimVie US Corp, LLC2026-09-21
K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare AB2026-08-06
K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.2026-07-01
K261122MIST ICImagine Milling Technologies, LLC2026-06-27
K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.2026-06-26
K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.2026-06-15
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