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FDA 510(k)

INCLUSIVE ZIRCONIA ABUTMENT BLANKS

K-Number: K083480 · 2009-05-05

ApplicantInclusive Dental Solutions
Decision Date2009-05-05
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INCLUSIVE ZIRCONIA ABUTMENT BLANKS is the device name listed in this FDA 510(k) record. The listed applicant is Inclusive Dental Solutions. It received FDA 510(k) clearance on 2009-05-05 under 510(k) number K083480. 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 ZIRCONIA ABUTMENT BLANKS?

INCLUSIVE ZIRCONIA ABUTMENT BLANKS is a medical device that received FDA 510(k) clearance on 2009-05-05. The listed applicant is Inclusive Dental Solutions. The 510(k) number is K083480.

When did INCLUSIVE ZIRCONIA ABUTMENT BLANKS receive FDA 510(k) clearance?

INCLUSIVE ZIRCONIA ABUTMENT BLANKS received FDA 510(k) clearance on 2009-05-05, under 510(k) number K083480.

Who is the listed applicant for INCLUSIVE ZIRCONIA ABUTMENT BLANKS?

The FDA 510(k) record lists Inclusive Dental Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INCLUSIVE ZIRCONIA ABUTMENT BLANKS?

The FDA product code for INCLUSIVE ZIRCONIA ABUTMENT BLANKS 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 Inclusive Dental Solutions 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.

K083192INCLUSIVE TITANIUM ABUTMENT BLANKSK073217INCLUSIVE IMPLANT ABUTMENTS

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.

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLCK253999Universal 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.

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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