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FDA 510(k)

X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE

K-Number: K042466 · 2004-11-24

ApplicantZest Anchors, Inc.
Decision Date2004-11-24
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE is the device name listed in this FDA 510(k) record. The listed applicant is Zest Anchors, Inc.. It received FDA 510(k) clearance on 2004-11-24 under 510(k) number K042466. 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 X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE?

X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE is a medical device that received FDA 510(k) clearance on 2004-11-24. The listed applicant is Zest Anchors, Inc.. The 510(k) number is K042466.

When did X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE receive FDA 510(k) clearance?

X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE received FDA 510(k) clearance on 2004-11-24, under 510(k) number K042466.

Who is the listed applicant for X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE?

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

What is the FDA product code for X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE?

The FDA product code for X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE is NHA.

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Other records listing Zest Anchors, 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.

K083324LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEMK072878MODIFICATION TO: LOCATOR IMPLANT ANCHORK033699LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586K994257LOCATOR IMPLANT ANCHORK925849ZEST IMPLANT ANCHORK934668ZEST IMPLANT ANCHOR ADVANCED GENERATION (DENTAL)

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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.

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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