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FDA 510(k)

Neodent Scannable Healing Abutment

K-Number: K253922 · 2026-06-15

ApplicantJJGC Indústria e Comércio de Materiais Dentários S.A.
Decision Date2026-06-15
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neodent Scannable Healing Abutment is the device name listed in this FDA 510(k) record. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K253922. 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 Neodent Scannable Healing Abutment?

Neodent Scannable Healing Abutment is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K253922.

When did Neodent Scannable Healing Abutment receive FDA 510(k) clearance?

Neodent Scannable Healing Abutment received FDA 510(k) clearance on 2026-06-15, under 510(k) number K253922.

Who is the listed applicant for Neodent Scannable Healing Abutment?

The FDA 510(k) record lists JJGC Indústria e Comércio de Materiais Dentários S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neodent Scannable Healing Abutment?

The FDA product code for Neodent Scannable Healing Abutment is NHA.

Other records listing JJGC Indústria e Comércio de Materiais Dentários S.A. 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.

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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.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLCK260564DESS Dental Smart SolutionsTerrats Medical SL

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.

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