Cleared Special

K083141 - SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM

K083141 is an FDA 510(k) clearance for SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM, manufactured by Simpact, LLC. The device is a Class 2 Dental device with product code NHA cleared through the Special 510(k) pathway after a 15-day FDA review.

K083141 · Simpact, LLC · Dental device
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Nov 2008
Decision
15d
Days
Class 2
Risk

K083141 is an FDA 510(k) clearance for the SIMPACT ENDOSSEOUS DENTAL 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 Simpact, LLC (Parsippany, US). The FDA issued a Cleared decision on November 7, 2008 after a review of 15 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 Simpact, LLC devices

FDA 510(k) Submission Details - K083141

510(k) Number K083141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2008
Decision Date November 07, 2008
Days to Decision 15 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 127d · This submission: 15d
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 567
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K083141.
SPI VARIOMULTI ANGLED ABUTMENT
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K081786 · Osstem Implant Co., Ltd. · Dec 2008
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K082545 · Institut Straumann AG · Oct 2008
ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS
K081666 · Astra Tech, Inc. · Oct 2008
STRAUMANN WN CARES TITANIUM ABUTMENT
K082764 · Institut Straumann AG · Oct 2008