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FDA 510(k)

Inclusive Abutments

K-Number: K160979 · 2016-11-04

ApplicantPrismatik Dentalcraft, Inc.
Decision Date2016-11-04
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Inclusive Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K160979. 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 Inclusive Abutments?

Inclusive Abutments is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K160979.

When did Inclusive Abutments receive FDA 510(k) clearance?

Inclusive Abutments received FDA 510(k) clearance on 2016-11-04, under 510(k) number K160979.

Who is the listed applicant for Inclusive Abutments?

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

What is the FDA product code for Inclusive Abutments?

The FDA product code for Inclusive Abutments is NHA.

Other records listing Prismatik Dentalcraft, 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.

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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.

K261147Neodent 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, 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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