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)

Elos Accurate® Customized Abutment

K-Number: K190299 · 2019-06-26

ApplicantElos Medtech Pinol A/S
Decision Date2019-06-26
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Elos Accurate® Customized Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Elos Medtech Pinol A/S. It received FDA 510(k) clearance on 2019-06-26 under 510(k) number K190299. 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 Elos Accurate® Customized Abutment?

Elos Accurate® Customized Abutment is a medical device that received FDA 510(k) clearance on 2019-06-26. The listed applicant is Elos Medtech Pinol A/S. The 510(k) number is K190299.

When did Elos Accurate® Customized Abutment receive FDA 510(k) clearance?

Elos Accurate® Customized Abutment received FDA 510(k) clearance on 2019-06-26, under 510(k) number K190299.

Who is the listed applicant for Elos Accurate® Customized Abutment?

The FDA 510(k) record lists Elos Medtech Pinol A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elos Accurate® Customized Abutment?

The FDA product code for Elos Accurate® Customized Abutment is NHA.

Other records listing Elos Medtech Pinol A/S 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.

K253774Elos Accurate® Denture Fixation SystemK251497Elos Accurate Hybrid BaseK242025Elos Accurate® Hybrid Base™K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentK231307Elos Accurate Customized AbutmentK230317Elos Accurate Hybrid Base

View all 13 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.

↑