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FDA 510(k)

Esthetic Abutments Nobel Biocare N1

K-Number: K220339 · 2022-09-16

ApplicantNobel Biocare Services AG
Decision Date2022-09-16
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Esthetic Abutments Nobel Biocare N1 is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare Services AG. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K220339. 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 Esthetic Abutments Nobel Biocare N1?

Esthetic Abutments Nobel Biocare N1 is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Nobel Biocare Services AG. The 510(k) number is K220339.

When did Esthetic Abutments Nobel Biocare N1 receive FDA 510(k) clearance?

Esthetic Abutments Nobel Biocare N1 received FDA 510(k) clearance on 2022-09-16, under 510(k) number K220339.

Who is the listed applicant for Esthetic Abutments Nobel Biocare N1?

The FDA 510(k) record lists Nobel Biocare Services AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Esthetic Abutments Nobel Biocare N1?

The FDA product code for Esthetic Abutments Nobel Biocare N1 is NHA.

Other records listing Nobel Biocare Services AG 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.

K231219NobelZygoma PureSet™ TrayK220048NobelProcera Zirconia N1 BaseK211109N1 TiUltra TCC Implant SystemK212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray

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

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

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