Cleared Traditional

K081396 - SWISSPLANT DENTAL IMPLANT SYSTEM

K081396 is an FDA 510(k) clearance for SWISSPLANT DENTAL IMPLANT SYSTEM, manufactured by Implant Direct, LLC. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K081396 · Implant Direct, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
240d
Days
Class 2
Risk

K081396 is an FDA 510(k) clearance for the SWISSPLANT 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 Implant Direct, LLC (Calabasas, US). The FDA issued a Cleared decision on January 14, 2009 after a review of 240 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Implant Direct, LLC devices

FDA 510(k) Submission Details - K081396

510(k) Number K081396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2008
Decision Date January 14, 2009
Days to Decision 240 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 127d · This submission: 240d
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 567
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K081396.
ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE
K083871 · Astra Tech, Inc. · Apr 2009
HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,
K090723 · Zimmer Dental, Inc. · Apr 2009
SPI VARIOMULTI ANGLED ABUTMENT
K090153 · Thommen Medical AG · Mar 2009
ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT
K083474 · Zimmer Dental, Inc. · Dec 2008
ZIOCERA & CONVERTIBLE SYSTEM
K081786 · Osstem Implant Co., Ltd. · Dec 2008
STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS
K082545 · Institut Straumann AG · Oct 2008