Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)

K-Number: K241003 · 2025-01-08

ApplicantHiossen, Inc.
Decision Date2025-01-08
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2025-01-08 under 510(k) number K241003. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)?

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) is a medical device that received FDA 510(k) clearance on 2025-01-08. The listed applicant is Hiossen, Inc.. The 510(k) number is K241003.

When did HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) receive FDA 510(k) clearance?

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) received FDA 510(k) clearance on 2025-01-08, under 510(k) number K241003.

Who is the listed applicant for HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)?

The FDA 510(k) record lists Hiossen, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)?

The FDA product code for HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) is NHA.

Other records listing Hiossen, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsK251427EK MULTI ANGLED 30 ABUTMENTK240232EK D3.3 and Ultra Wide ImplantsK233389EK Digital AbutmentsK222636ET Abutment SystemK203360EK Implants and Abutments System

View all 16 devices →

Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑