Cleared Abbreviated

K083480 - INCLUSIVE ZIRCONIA ABUTMENT BLANKS

K083480 is an FDA 510(k) clearance for INCLUSIVE ZIRCONIA ABUTMENT BLANKS, manufactured by Inclusive Dental Solutions. The device is a Class 2 Dental device with product code NHA cleared through the Abbreviated 510(k) pathway after a 162-day FDA review.

K083480 · Inclusive Dental Solutions · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
162d
Days
Class 2
Risk

K083480 is an FDA 510(k) clearance for the INCLUSIVE ZIRCONIA ABUTMENT BLANKS. 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 Inclusive Dental Solutions (Newport Beach, US). The FDA issued a Cleared decision on May 5, 2009 after a review of 162 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Inclusive Dental Solutions devices

FDA 510(k) Submission Details - K083480

510(k) Number K083480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2008
Decision Date May 05, 2009
Days to Decision 162 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 127d · This submission: 162d
Pathway characteristics
Standards-based clearance path.

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 567
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K083480.
SPI CUSTOMIZABLE GINGIVA FORMER
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