Cleared Special

K040539 - ELLIPTIC MATRIX

K040539 is an FDA 510(k) clearance for ELLIPTIC MATRIX, manufactured by Institut Straumann AG. The device is a Class 2 Dental device with product code NHA cleared through the Special 510(k) pathway after a 16-day FDA review.

K040539 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
16d
Days
Class 2
Risk

K040539 is an FDA 510(k) clearance for the ELLIPTIC MATRIX. 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 Institut Straumann AG (Waltham, US). The FDA issued a Cleared decision on March 18, 2004 after a review of 16 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.

View all Institut Straumann AG devices

FDA 510(k) Submission Details - K040539

510(k) Number K040539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2004
Decision Date March 18, 2004
Days to Decision 16 days
Submission Type Special
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
111d faster than avg
Panel avg: 127d · This submission: 16d
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 653
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K040539.
RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT
K041295 · Institut Straumann AG · May 2004
NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236
K040573 · Nobel Biocare Uas, Inc. · Apr 2004
3I PATIENT-SPECIFIC OVERDENTURE BAR
K034035 · Implant Innovations, Inc. · Mar 2004
NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236
K033724 · Nobel Biocare Uas, Inc. · Feb 2004
SPI EASY DENTAL IMPLANT PROTECTIVE CAP
K033346 · Thommen Medical AG · Nov 2003
ITI SYNOCTA MESO ABUTMENTS
K033243 · Straumann USA · Oct 2003