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Patient Information
Is the Mini Dental Implant FDA approved? When can Mini Dental Implants be used? What's the primary and most effective use for Mini Dental Implants? How specifically can Mini Dental Implants help denture wearers? You've told us about the diameter of the Mini Dental Implants. How long are they? What Are Mini Dental Implants?
Is the Mini Dental Implant FDA approved?Yes. Prior to his preliminary discussions with Dr. Bulard, Dr. Sendax had submitted a formal application to the FDA in Washington, DC seeking permission to market the mini dental implant devices to the general public. After providing satisfactory technical and clinical evidence to that agency that the product was safe for public use and in fact had beneficial attributes, the FDA granted its formal consent to market the Mini Dental Implant device not only as a transitional or temporary dental product, but significantly, as a long-term item. (IMTEC was the first company to receive long-term approval of its MDI implants from the FDA and for several years was the only company to have that distinction.) As stated, IMTEC's introduction of the Mini Dental Implant to the dental industry and appropriate marketing efforts under a license granted by Dr. Sendax followed the FDA's consent to market.
When can Mini Dental Implants be used?When critically needed for support purposes and where solid bony adaptation (integration) has clearly occurred, mini implants can function as long-term supporting structures rather than as short-term or medium term devices. In fact, some have been successfully functioning in patients' jaws for several decades. In the past several years, some clinicians have been utilizing MDI's for single tooth replacements and in crown and bridge cases.
What's the primary and most effective use for Mini Dental Implants?The most effective use of this unique dental product is stabilization
of a lower denture. There are approximately 50,000,000 people in the
United States who are "edentulous" (literally meaning lacking
teeth) who struggle daily with prosthetic devices. A majority suffer
a great deal of discomfort as a result of loose or ill-fitting
How specifically can Mini Dental Implants help denture wearers?The standard insertion protocol for mini dental implants calls for four of them to be gently screwed into the front of a patient's lower jaw. This is a relatively painless procedure that can be performed by a general dentist, requiring only a mild anesthesia. The mini dental implants, which are approximately the size of wooden toothpicks, are placed about five millimeters apart in the patient's mandible. The patient's denture is then carefully adjusted by the dentist to allow it to snap onto the four mini implants. The result? A tight fitting, completely reliable system that allows a patient to speak and eat with confidence. The Mini Dental Implants are placed in about an hour's time. Because of the unique, minimally invasive procedure, the minute size of the implants and the characteristic placement area, the typical Mini Dental Implant patient can enjoy a light meal an hour or so after having the mini implants placed. Further, a denture patient who has had his or her prosthesis stabilized with MDI can remove and replace the denture easily after a little practice and can easily utilize good dental hygiene. All in all, the MDI is quite satisfying.
I'm somewhat aware of the tremendous forces the human jaw usually endures during normal chewing of food. How can these tiny Mini Dental Implants withstand that? It's true that what the dental profession calls occlusal forces
create dynamic pressures on the human jaw. Our jaws are marvelously
designed to adequately withstand those forces. It's also true that
mankind has been struggling for centuries to come up with some type
of metal or metallic element that can efficiently withstand those
forces. Most have been outright failures. However, approximately twenty-five
years ago some doctors around the world began experimenting with titanium
as a potential dental medium. Titanium is an extremely strong metal
used in the construction of aircraft and aircraft engines. The metal,
in its commercial form, is incredibly strong and durable. The Sendax
Mini Dental Implant takes that metallurgical concept to the next level
by adapting an industry approved alloy of titanium. The result is
the strongest metal on earth, now commonly referred to as titanium
alloy. In fact, extensive tests conducted several years ago by the
University of Alabama-Birmingham School of Orthopedics at Dr. Sendax's
behest
You've told us about the diameter of the Mini Dental Implants. How long are they?
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Mini
dental implants are ultra-small diameter (l.8 millimeter width), biocompatible
titanium alloy implant screws, conceived and designed over 20 years
ago by a dentist, Victor I. Sendax, DDS. Dr. Sendax originally created
the unique design of this dental product as a transitional device
to help support fixed bridge replacements for lost teeth. His novel
theory was that mini implants could function free standing by themselves
or in combination with natural tooth supports and/or larger conventional
type dental implants. This was a revolutionary concept in dental science.
Late in l997, Dr. Sendax collaborated about his mini implant theory
and design concepts with a colleague, Dr. Ronald A. Bulard. Dr. Bulard
had previously formed a dental implant company, IMTEC Corporation,
which was at the time manufacturing and marketing standard sized dental
implants, abutments and other dental products. Convinced they were
on to something special, the two implantologists spent countless hours
studying and refining Dr. Sendax's original creative design, resulting
in a more efficient top and collar to the mini dental implants. Combining
this now re-designed mini implant with Dr. Sendax's original insertion
protocol resulted in a successful breakthrough. Under Dr. Bulard's
direction, IMTEC Corporation began the rather complex and expensive
design and manufacturing procedures which ultimately resulted in what
is now offered to the dental community under the brand name IMTEC
Sendax MDI (mini dental implant). The innovative system and procedure
was thereafter formally introduced to the United States dental community
at an implant conference in Orlando, Florida in April, 1999. It was
an instant success and now represents one of the fastest growing segments
of the dental product industry.
dentures. Many denture wearers simply withdraw from any type of social
engagement as a result of being compelled to wear them. Moreover,
it's not uncommon for family members to complain about a denture wearer's
disagreeable breath as a result of food being trapped and decaying
under their denture prosthesis. Successful placement of the Mini Dental
Implant addresses and solves all of these social and practical problems.
Denture patients all over the world have experienced relief from loose
or ill-fitting dentures from doctors who are trained to place the
MDI. Uniquely, the MDI can be utilized to stabilize a denture in a
couple of hours by a trained doctor, allowing the patient to leave
the clinic with a stabilized prosthesis.
revealed
that the particular titanium alloy implants used in the IMTEC Sendax
Mini Dental Implants are 64% stronger than ones constructed of commercially
pure titanium. The bottom line of this discussion area is simple:
If a denture patient has sufficient bone mass to create a rock hard
placement of the tiny implant, which an experienced dentist can usually
determine by an initial examination, the mini dental implants will
generally withstand normal chewing forces just like natural teeth.
Fractures are extremely rare, but as the case with a person's normal
teeth, can certainly occur.
IMTEC
Corporation manufactures and sells the Mini Dental Implants in four
lengths, 10, 13, 15 & 18 mm's. One trained in dental science will
recognize instantly that these lengths appropriately anticipate the
type of depths that are needed in a wide variety of prospective Mini
Dental Implant patients. The company also manufactures what it calls
the Mini Dental Implant MAX that's sold in 10, 13, 15 & 18 mm's.