Cleared Special

K042466 - X-2 IMPLANT ABUTMENT

Also marketed or referenced as:
BAR MALE DISTAL EXTENSION MALE

K042466 is an FDA 510(k) clearance for X-2 IMPLANT ABUTMENT, manufactured by Zest Anchors, Inc.. The device is a Class 2 Dental device with product code NHA cleared through the Special 510(k) pathway after a 72-day FDA review.

K042466 · Zest Anchors, Inc. · Dental device
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Nov 2004
Decision
72d
Days
Class 2
Risk

K042466 is an FDA 510(k) clearance for the X-2 IMPLANT ABUTMENT. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Zest Anchors, Inc. (Escondido, US). The FDA issued a Cleared decision on November 24, 2004 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K042466

510(k) Number K042466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2004
Decision Date November 24, 2004
Days to Decision 72 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 128d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 715
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K042466.
TITAN DENTAL IMPLANT ATTACHMENT
K042715 · Titan Implants, Inc. · Mar 2005
ATLANTIS ABUTMENT FOR STRAUMANN INTERFACE
K050052 · Atlantis Components, Inc. · Mar 2005
SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K043190 · Innova Life Sciences Corp. · Dec 2004
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
K043042 · Nobel Biocare AB · Nov 2004
PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004
K042658 · Nobel Biocare Uas, Inc. · Oct 2004
STRAUMANN TEMPORARY COPING
K041070 · The Straumann Co. · Jul 2004
K042466 · X-2 IMPLANT ABUTMENT
Download PDF Zest Anchors, Inc.