Cleared Traditional

K083544 - KAT IMPLANT SYSTEM

K083544 is an FDA 510(k) clearance for KAT IMPLANT SYSTEM, manufactured by Kat Implants, LLC. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K083544 · Kat Implants, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
66d
Days
Class 2
Risk

K083544 is an FDA 510(k) clearance for the KAT IMPLANT SYSTEM. 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 Kat Implants, LLC (Portsmouth, US). The FDA issued a Cleared decision on February 2, 2009 after a review of 66 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K083544

510(k) Number K083544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2008
Decision Date February 02, 2009
Days to Decision 66 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 128d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K083544.
INCLUSIVE TITANIUM ABUTMENT BLANKS
K083192 · Inclusive Dental Solutions · Mar 2009
NEOSS ACCESS ABUTMENTS
K081851 · Neoss, Ltd. · Mar 2009
LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM
K083324 · Zest Anchors, Inc. · Feb 2009
SPECTRA-SYSTEM ABUTMENTS 2008
K081101 · Implant Direct, LLC · Jan 2009
SWISSPLANT DENTAL IMPLANT SYSTEM
K081396 · Implant Direct, LLC · Jan 2009
ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT
K083474 · Zimmer Dental, Inc. · Dec 2008
K083544 · KAT IMPLANT SYSTEM
Download PDF FDA Summary Kat Implants, LLC