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510(k) K190048

Device
UF(II) Anatomic Abutment
Applicant
DIO Corporation
510(k) number
K190048
Product code
NHA  
Decision
Substantially Equivalent (SESE)
Decision date
2019-09-30
Date received
2019-01-10
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
Jiae Park
Address
66 Centumseo-Ro, Haeundae-Gu Busan KR 48058 48058

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
K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S2026-09-30
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

Legacy Summary#

summary

FDA Review#

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