BIO-LIFE DENTAL
IMPLANT SYSTEMS
An American Medical Device Manufacturing Company
The only patented surgical-prosthetic "no -inventory-needed" kit sold in the world.
The Concept of "THE KIT" Prosthetic Section contains: 'THE KIT' is also color coded through an anodization process to eliminate the possibility of error. It has also been proven that the anodization process assists in implant integration. CAUTION: Federal (USA) law restricts this device to be sold only to a licensed dentist or physician. Temporary Contraindications: Anatomical or Pathological Contraindications: CAUTION: Drills should be replaced when wear is noted. Bio-Life recommends replacement of drills after 20 osteotomies. SYSTEM DESIGN
The concept of the 'Surgical-Prosthetic Kit' was developed by Bio-Life, L.L.C. to eliminate confusing inventory and expensive components, thus making it THE MOST cost effective dental implant system in today's market.
US Patent #'s 5,468,149,& 5,755,574 and Canada 2,123,592
'THE KIT' is comprised of a 'Surgical Section' and a 'Prosthetic Section'
Surgical Section contains:
PACKAGING
The Bio-Life Dental Implant System contains five separate components. All components are non-sterile with the exception of the implant body that is provided sterile within a double vial heat sealed wrapping.
All packages containing implants or components should be intact upon receipt. If the package or product is damaged, the product should not be used and should be returned to Bio-Life Dental Implant Systems, LLC for replacement or credit. Once implanted, the product should never be reused.
INDICATIONS FOR USE
The Bio-Life Dental Implant System is a two stage implant system intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The Bio-Life Dental Implant System may also function as a terminal or intermediate support for fixed bridgework.
CONTRAINDICATIONS FOR USE
General Medical Contraindications associated with elective surgical procedures should be observed. Included, but not limited to, are significant vascular impairment to the implant site; metabolic bone disease; clotting disorders; current treatment with therapeutic agents that may have an effect on the surgical site, surrounding tissues or normal healing responses. For example, drug therapy, chemotherapy, chronic steroid treatment, anticoagulant therapy or any other metabolic or physical disorders that interfere with bone growth, maintenance or would healing.
Possible Contraindications:
WARNINGS
Improper technique can contribute to implant failure and/or loss of bone. The Bio-Life Dental Implant System is intended to be used only in the indicated applications. Dental implants must not be altered in any way. Abutments and attachments supplied by other implant manufacturers might not be made to the same standards and tolerances as Bio-Life Dental Implants and should not be substituted. Substitution of components, other that Bio-Life components, may contribute to implant failure, prosthesis failure and/or loss of bone.
The use of electro-surgical instruments or lasers around metallic implants and their abutments is discouraged due to the potential risk of electric and/or head conductivity to the substrate metal.
If the implant becomes contaminated by the patient's body fluids or tissues in any way, the implant cannot be used in any other patient. The implant may not be clean or re-sterilized for use in another patient.
Do not attempt to decontaminate the implant by any in-office method.
Modifications to implants (not recommended) and/or abutments may transmit heat to the implant body and surrounding bone, which may cause bone loss and contribute to implant failure. External irrigation may prevent bone loss if modifications must be done in the mouth. All major modifications to abutments must be done outside of the mouth with only minor light modifications made with the abutment in the implant body.
ADVERSE REACTIONS
Some of the complications that can occur are: infection, bone loss, patient discomfort, implant mobility, local soft tissue degeneration and unfavorable implant placement or alignment.
Standard dental treatment procedures should be applied for: infection, bone loss, patient discomfort, implant mobility and local soft tissue degeneration as would be indicated and/or applied to natural teeth. These would include pain medications, antibiotics, removal from function, removal of mobile implants and soft tissue/bone
de-bridement and augmentation.
Implant mobility, bone loss or chronic infection may indicate implant failure. Any implant that appears to be failing, should be treated as soon as possible. If the removal of the implant is deemed necessary, any soft tissue can be curetted from the implant site and the site allowed to heal in the same manner as a traumatic natural tooth extraction.
Unfavorable implant placement or alignment may be treated with the use of customized abutment up to 30 degrees. In the event implant placement is such that the implant is unrestorable due to alignment or positioning either with the natural dentition or other implants, the implant may need to be left unloaded or removed.
STERILITY
The Bio-Life Dental Implant System implants are provided in sterile gamma irradiated packaging. The inner vial (the implant body, the bone healing cap and the transfer handle) are sterile unless the outer vial seal has been damaged or opened.
Use only sterile, powder free, starch free and talcum free gloves during the procedure.
It is important to keep all instruments (surgical hand piece and equipment) sterile to prevent the possible contamination of the components, the surgical system and thus the patient. Always run a system check and have a back-up equipment, implants and instrumentation in case of contamination or failure of equipment or instrumentation.
PRE-OPERATIVE PROCEDURES
The implant placement procedure should be done under aseptic conditions with specifically designed sterile surgical instruments. A surgical drilling sequence for placement of implants should be followed. When drilling with a pilot, intermediate and final spade drill use a gentle 'in-and-out' motion. (NOTE: Always maintain control of the drill when entering the bone.) The use of surgical guides, study models and depth gauges are recommended to aid in implant placement and positioning.
PRECAUTIONS
The surgical techniques required to place endosseous dental implants, although described in some detail in this manual, require highly specialized and complex procedures. Formal training in the placement of such implants is strongly recommended. Practitioners should attend courses of study in established techniques of oral implantology.
It is very important to determine local anatomy and suitability of the available bone (bone volume) for the implant placement. Adequate radiographs, direct palpation and visual inspection of the prospective implant site are necessary prior to treatment, planning and implant use.
INSTRUMENTATION
Bio-Life does not provide instruments marked sterile. Non-sterile instruments must be washed and sterilized prior to use. Always remove instruments from the packaging prior to sterilization. Double-check your surgical instrumentation to ensure the sterility and functionality.
Cleaning the Surgical Tray:
Sterilization Table:
The Bio-Life Dental Implant System is designed and manufactured in such a way that, when used under the conditions and for the purpose intended, will not compromise clinical conditions, the safety and health of patients or of the users themselves. We pride ourselves by maintaining a high level of protection for all consumers, by strictly abiding by all rules and regulations required by the United States Food & Drug Administration (FDA).
(See FDA FMD415)
The Bio-Life Dental Implant System is a titanium alloy implant that integrates with the maxillary or mandibular bone to form a rigid abutment for a dental prosthesis. The implant body is produced with either a rough blasted medium (RBM) creating a roughened titanium surface or a Hydroxylapatite coated titanium surface.
The Bio-Life Dental Implant is designed for use in the mandible and the maxilla, in both partial and fully edentulous situations. It can be used as a terminal abutment, inter-dental abutment or a stand-alone abutment in a single tooth replacement.
A system and control are in place for personnel, cleanliness, health requirements, bio-burden testing and validation of sterilization has been performed and is revalidated on a yearly basis.
All materials used meet standards for implantable surgical use. A fatigue test has been conducted to ensure the product adequately functions for its life expectancy. Calibration is not required for this product.
PRODUCT SPECIFICATIONS
