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 711)

Showing 20 most recent of 711 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K261122MIST ICImagine Milling Technologies, LLCJun 27, 2026SESE
K260061BioHorizons CEREC Compatible Ti-Bases (TP3CTB1~PBCTB3 and CNTE0~CRTE2)BioHorizons Implant Systems, Inc.Jun 26, 2026SESE
K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.Jun 15, 2026SESE
K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLCJun 11, 2026SESE
K260564DESS Dental Smart SolutionsTerrats Medical SLJun 9, 2026SESE
K252904SIC Abutments including CAD/CAM SolutionsSic Invent AGJun 3, 2026SESE
K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/SMay 20, 2026SESE
K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.May 14, 2026SESE
K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AGMay 7, 2026SESE
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

Top Applicants

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