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FDA 510(k)

Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV

K-Number: K191222 · 2019-08-05

ApplicantPrismatik Dentalcraft, Inc.
Decision Date2019-08-05
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV 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 2019-08-05 under 510(k) number K191222. 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 Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV?

Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV is a medical device that received FDA 510(k) clearance on 2019-08-05. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K191222.

When did Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV receive FDA 510(k) clearance?

Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV received FDA 510(k) clearance on 2019-08-05, under 510(k) number K191222.

Who is the listed applicant for Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV?

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 Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV?

The FDA product code for Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV is NHA.

Related Clinical Trials

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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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.

K262239Obsidian® Press Over ZirconiaK254283BruxZir® Shaded 16 PLUSK252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant SystemsK252446BruxZir® NOWK250302Flexible Partial ResinK242564Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)

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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.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.

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