NHA · Abutment, Implant, Dental, Endosseous

Dental · 21 CFR 872.3630 · Class 2

Overview

Product CodeNHA
Device NameAbutment, Implant, Dental, Endosseous
Regulation21 CFR 872.3630
Device ClassClass 2
Review PanelDental
ImplantYes

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Classification Rationale

Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Recent Cleared Devices (20 of 702)

Showing 20 most recent of 702 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K253804DESS Dental Smart SolutionsTerrats Medical SLApr 16, 2026SESE
K260555LOCATOR® Angled AbutmentZest Anchors, LLCApr 9, 2026SESE
K251434Healing Abutment SystemOsstem Implant Co., Ltd.Mar 4, 2026SESE
K251515Solidex® Ti-Links and ScrewsCreoDent Hudson ValleyFeb 10, 2026SESE
K251427EK MULTI ANGLED 30 ABUTMENTHiossen, Inc.Jan 29, 2026SESE
K243732Multi-Unit DAS SystemTalladium España, SLJan 29, 2026SESE
K253315Straumann Variobase Abutments XC for Bridge/BarInstitut Straumann AGJan 22, 2026SESE
K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.Jan 22, 2026SESE
K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.Jan 7, 2026SESE
K253341Custom Abutments ASMedentika GmbHDec 23, 2025SESE
K253312OrangeCAD Med AbutmentsOrangecad Med GmbHDec 23, 2025SESE
K252320SIMDA AbutmentsSimda Co., Ltd.Dec 18, 2025SESE
K252343Atlantis® Abutments in TitaniumDentsply SironaDec 9, 2025SESE
K252248CEREC Tessera Abutment SystemDentsply SironaNov 26, 2025SESE
K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply SironaNov 21, 2025SESE
K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant SystemsPrismatik Dentalcraft, Inc.Nov 18, 2025SESE
K251547DESS Dental Smart SolutionsTerrats Medical SLOct 31, 2025SESE
K252384DESS® Dental Smart SolutionsTerrats Medical SLOct 23, 2025SESE
K252266S.I.N. Dental Implant SystemS.I.N. Implant System LtdaOct 17, 2025SESE
K250178Adin Customized AbutmentsAdin Dental Implant Systems , Ltd.Oct 17, 2025SESE

Top Applicants

Innolitics

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