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Clinical evidence

The expandable implant has been placed since the early 1990s. Independent evaluation, prospective survival data, bench testing and the original published description — every document below opens in full so you can read it yourself.

Prospective survival study

273 of 286
implants survived.

Up to 40 months 75 patients Immediate & delayed loading

"Freestanding and multiunit immediate loading of the expandable implant; an up-to-40-month prospective survival study."

Two hundred and eighty-six immediate-load Sargon® implants were placed in 75 patients over a 40-month period. Of the 273 implants that survived, 81 were placed into fresh extraction sockets and immediately loaded, 162 were placed into healed sites and immediately loaded, and 30 were delay loaded.

Young Hwan Jo, DDS, MSD, PhD; Peter K. Hobo, DDS; and Sumiya Hobo, DDS, MSD, PhD — Seoul Dental Institute, Seoul, Korea, and the International Dental Academy, Tokyo, Japan.


Independent evaluation

University of
Southern California.

Advanced Periodontics 1997

"Evaluation of Sargon® Immediate Load Implant (Ultra Tooth)."

An evaluation of the immediate-load implant carried out through the Advanced Periodontics programme at the USC School of Dentistry, examining the clinical and microbiological behaviour of hard- and soft-tissue integrated implants against the prevailing two-stage technique described by Brånemark and the one-stage technique described by Schroeder.

Hessam Nowzari, DDS, PhD — Director, Advanced Periodontics; Diplomate, American Board of Periodontology; Associate Professor of Clinical Dentistry, University of Southern California School of Dentistry. Dated 4 November 1997.


Mechanical testing

Bench-tested to
a written protocol.

Static & fatigue 16 mm assemblies 15° angled abutment

Independent laboratory testing of Ultratooth® implant assemblies was carried out by ARTECH, an engineering test house, under a written test protocol. The static test specified five sets of implant and abutment assemblies, each implant installed in a vertical hole drilled in a test fixture and loaded through a 15° angled abutment.

Tested assemblies were examined under an optical microscope at 30× magnification; no damage to the implants or abutments was observed. The protocol, the results and the separate leak-testing report are all published in full below.


Original description

Dentistry Today,
April 1992.

First published case series

"Immediate-Load Implant Quickens Integration."

Writing in Dentistry Today in April 1992, Dr. Sargon Lazarof set out the case for an implant that integrates and loads immediately, against a standard of care that then required roughly four months for mandibular integration and six for maxillary. The article introduced the precursor design and the argument that would become the expandable implant.

Sargon Lazarof, DDS. Dentistry Today, April 1992.

Document library

Read it all
for yourself.

Every document referenced on this page, in full. Each opens in a new tab — no form, no registration.

Clinical articles

Studies & evaluations

Bench testing

Regulatory

Clearances and
registrations.

Biodent Inc. is an FDA-registered establishment. Each implant family is cleared under its own 510(k) number.

FDA references
ReferenceDevice name as clearedCleared
K981141Sargon Immediate Load Implant — Ultratooth Model23 Jun 1999
K961005Sargon Immediate Load Implant6 May 1996
K930071Sargon Cylindro-Blade Implant8 Jul 1994
K082573Sargon Non-Expandable Dental Implant21 Jul 2010
2085360Biodent Inc. — FDA establishment registrationActive

Indications for use, as cleared

The wording below is the Indications for Use statement cleared by the FDA Center for Devices and Radiological Health under 510(k) K981141, for the device named “Sargon Immediate Load Implant — Ultratooth Model”:

“For immediate load use, without an abutment, in either partially or fully edentulous mandibles and maxillae, for fixed or detachable prosthesis and for use in support of free-standing restorations with or without the involvement of adjacent dentition.”

Cleared for prescription use per 21 CFR 801.109. The clearance record and 510(k) summary are public and searchable by K number in the FDA 510(k) database.

Looking for something not listed here? Additional papers, test reports and the controlled revision of the Instructions for Use are provided to licensed dental professionals, institutional reviewers and regulatory bodies on request. Contact Biodent with the reference you need.