Regulatory Approvals

  CE Mark
Certificate PDF Version

ISO 13485:2003
Certificate Verification

ISO-CMDCAS
Certificate PDF Version

FDA 510(K)
Marketing Clearance


The founder of Implant Direct and developer of its Spectra-System of "Application Specific" implants, Dr. Gerald Niznick, has a 25-year history of innovations in the dental implant industry. Referred to in Barrons Magazine (02/14/05) as the "Godfather of American Implant Dentistry," Dr. Niznick's philosophy has always been to provide high quality, innovative dental implants at cost-effective prices. It started when Dr. Niznick introduced the Core-Vent implant system in 1982, launching the concept of simplified surgical procedures and versatile prosthetic application. In 1986, he developed the self-tapping *Screw-Vent Implant with its internal hex-thread connection, considered to be the cornerstone for modern dental implant designs. In 1997, Core-Vent changed its name to Paragon Implant Company. To live up to the Paragon name, Dr. Niznick designed the Tapered *Screw-Vent for two-stage surgery and the Tapered *Advent for one-stage surgery, both with the same body design and dimensions allowing insertion with the same set of surgical instruments. This revealed a glimpse of what Dr. Niznick would ultimately develop, a spectrum of seven application specific implants, all with the same body design and dimensions.

By 2004, 3 years after Dr. Niznick sold Paragon Implant Company to SulzerMedica (acquired by Zimmer Dental), Dr. Niznick formed Implant Direct LLC and re-occupied his implant factory following the expiration of Zimmer's lease. Implant Direct hired 50 former Paragon and Zimmer machinists, engineers and quality control people and by 2006, when Dr. Niznick's non-compete expired, Implant Direct's team had grown to 85 with 26 new machines operating 24/7. By July, 2007, the number of employees has grown to 115 employees and Implant Direct has opened a new office to accommodate 16 technical support/customer service personnel and to respond to the many inquiries from potential new customers. Implant Direct has established offices in Canada and Israel and is setting up Implant Direct EU in Switzerland plus a network of distributors in Asian countries, Turkey, Egypt and throughout South America.

 

On October 1, 2006, Implant Direct received FDA510(k)Marketing Approval for the sale of Spectra-System consisting of 8 implants, 7 of which are designed with the same body but with different application specific platforms, and therefore can be inserted using the same set of surgical instruments (compatible with Zimmer Dental's *Screw-Vent drills). The 8th implant in the Spectra-System is called RePlant, and it is designed for both surgical and prosthetic compatibility with Nobel Biocare's Tapered Replace implant. Implant Direct's business strategy includes providing all-in-one packaging for most of its implants (implant, abutment, healing collar, transfers) and to sell factory-direct through the internet at 50-75% less than the major implant companies.

 

Implant Direct is able to provide customer service support 24/7 with online ordering and information about compatible products, as well as computer graphic animations to answer the more common surgical, prosthetic and laboratory questions. Implant Direct also offers the industry's first online, patient specific charting program for treatment planning, ordering, inventory control and team communications. According to a 8/15/05 Orthopedic News Report, "Dr. Niznick's web-based business model... may portend a paradigm shift in the entire industry."