Company Overview. Intra-Lock History.
Nano-profilomatry and calcium impregnated
surface is found on all Intra-Lock implants.
The Cutting Edge.
Helical Self-Tapping Configuration
Better Healing From Within.
IntraSpin™, a FDA cleared medical device for
the production of L-PRF™
One connection for ALL implant diameters...
one very special implant system.
InDex™ has multiple implant architectures, both
Tapered and Straight Bodies, included in this internal
connection implant system.
Designed for Extraction
& IMMEDIATE PLACEMENT.
Premier small diameter system features
one-step delivery, Cement-Over Abutments,
multiple tread designs
A true convertible implant with onepiece
solid strength and two-piece versatility.
Universal Hex Connection
3.0 to 4.75mm, One Piece Implants.
Indications for Dental Implants
Intra-Lock® Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or the maxilla and to support removable or fixed prostheses, from single tooth replacement to full arch reconstruction.
Intra-Lock® Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.
Indications for the MILO™ Dental Implant System
MILO™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. They are also indicated for the rehabilitation of single or maxillary lateral incisors and mandibular lateral and central incisors. Multiple implants may be restored after a period of time or placed in immediate function.
Indications for the MDL® Mini Drive-Lock™ Dental Implant System
MDL® Dental Implants, are intended for use as a self-tapping titanium screw for transitional or intra-bony long-term applications.
MDL® Dental Implants are also indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants should be used and may be restored after a period of time or placed in immediate function.
Indications for Dental Abutments
Intra-Lock® abutments are intended for use with Intra-Lock® dental implants to support a prosthetic device in partially or fully edentulous patients. The abutments may be used in single and/or multiple tooth application in the mandible or maxilla.
Patients with alcohol addiction or psychiatric disorders, blood dyscrasias, uncontrolled diabetes, hyperthyroidism, oral infections, malignancies or patients who have had myocardial infarction within the last 12 months.
Patients with systemic diseases that compromise the immune system, such as AIDS, patients on medications that would compromise healing of an implant site, patients with a history of poor or noncompliance to oral hygiene procedures, or patients who cannot maintain oral hygiene procedures if implants are placed. Tobacco usage increases the occurrence of complications and failures.
Intra-Lock® implants and abutments are manufactured from Titanium 6A-4V ELI Alloy, ASTM F136 or Commercially Pure Titanium, ASTM F-67.
Intra-Lock® dental implants are provided sterile (by gamma radiation) and are intended for single use only.
Packaged implants are suspended on a titanium or polycarbonate support ring within a clear vial. This vial is placed into a Seal PacTM plastic vial with a tamper evident seal, which provides an additional environmental barrier. The label on the package provides the lot number, product name, catalog reference number and expiration date.
To ensure sterility, dental implants must be used before the end of the expiration date indicated on the outer package label.
Intra-Lock® dental abutments are non-sterile and intended for single use only. Abutments should be sterilized prior to use by the instructions provided.
Prior to using Intra-Lock® dental implants and abutments, inspect the package and labeling for integrity. If the device is opened, damaged or contaminated in any way, it must not be used.
Never reuse, reclean or resterilize a dental implant. These activities can adversely affect implant materials and alter the surface characteristics, which may result in poor function and implant failure.
Preoperative Treatment Planning
Proper patient selection is important. A comprehensive patient interview and medical/dental history must be taken. A complete oral examination should then be conducted. Head and neck examination is followed by a thorough oral examination. The use of magnification is strongly encouraged as an adjunct to all procedures.
Oral inspection includes palpation and the proper radiographic protocol(s). This may include periapicals, panorex and tomograms. Palpation of the ridges is also required and the use of intra-oral probes for tissue thickness is recommended.
The diagnostic procedures will give the dentist an appreciation for the tissue quality and thickness, ridge morphology for the type and size of the implants that might be required. Measurements for implant size can be estimated utilizing radiographs, templates, calipers and millimeter rulers.
Treatment planning should also take into consideration prosthetic biomechanics, occlusion and occlusal load. Fracture due to excessive load or metal fatigue can occur on the implant body or it’s prosthetic components if this aspect of planning is inadequate.
In overdenture cases four or more implants should be utilized for maxillary or mandibular tissue-supported denture stabilization. When fixed prosthetics are utilized in single stage surgical procedures, implants may be loaded immediately following insertion provided at least four implants are placed and are splinted with a bar. These implants should be placed principally in the anterior mandible, between the mental foramina, where good initial stability of the implants can most often be achieved.
As with all surgical procedures, the operatory field should be maintained with sterile coverings (light handles, chair controls, bracket tray, and all instruments and components). Barrier technology, sterile solutions and sprays, sterile coverings, and proper autoclaving techniques must be employed as indicated.
Sterilization of Abutments
Abutments may be sterilized using a full cycle pre-vacuum steam sterilization at a temperature of 132°C for an exposure time of 3 minutes and 5 minute drying time.
Notice: It is critical that all bone-cutting procedures must be CONDUCTED AT SLOW SPEEDS. Profuse, internal and/or external irrigation is mandatory.
The slow-speed, highly irrigated drilling procedure is conducted while angling the drill such that the direction of the drill bisects the ridge. The drill should also be held vertically, avoiding a mesial or distal cant. Depth gauge/alignment components can be periodically inserted into the osteotomy site to monitor the angle of penetration. Successively larger drills are used until the desired diameter is achieved. Drilling is performed with a precise, up and down pumping action.
The drill angle is maintained in order to preserve the concentricity of the hole, while the pumping action allows for incremental depth penetration and periodic cleansing of the flutes.
Important Points to Remember
• The Conic Implants have a tapered thread body and are designed to fit the drilled depth.
• The final seating of the implant(s) should be achieved by the incremental turns of the Ratchet Wrench.
• Radiograph(s) should confirm proper depth, seating, orientation and placement of the implant(s).
• If a removable prosthesis is used near the implant site, in process of healing, it should be generously relieved and a soft tissue conditioner reline material placed.
Cold packs are recommended for the first 24 hours. Analgesics/Antibiotics may be prescribed at the discretion of the practitioner. The patient should be advised to favor the opposite side of the mouth, maintain a soft diet and avoid hot liquids.
Note: The Intra-Lock® Dental Implant System has not been evaluated for safety and compatibility in the MR environment. The Intra-Lock® Dental Implant System has not been tested for heating or migration in the MR environment.
• Dental implant surgery is a complex dental procedure. Appropriate and adequate training in all phases of implant procedures and proper technique is strongly recommended prior to implant use.
• Improper patient selection, diagnosis, treatment planning or technique can result in implant failure and/or loss of supportive bone.
• Care must be taken if performing electrosurgery around a dental implant. Electrosurgery generates heat, which can be conducted through a metallic implant and cause damage to surrounding tissue or bone.
• The use of small diameter implants and angled abutments in the posterior region of the mouth is not recommended due to possible failure of the implant.
• The external surface of Intra-Lock® Dental Implants should only come in contact with titanium surfaced instruments.
ReOss® is a hydrophilic, highly porous, resorbable, synthetic copolymer permeated with osteoconductive particles of Hydroxyapatite. It is configured as a multi-pore three - dimensional scaffold that creates an environment suitable for the infusion of blood and osteoblasts and is engineered to integrate with the physiochemical state of bone tissue.
Indications for Use
ReOss® Powder and Putty is indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites and sinus elevation grafting.
Standard protocols are to be followed when taking a comprehensive medical/dental history.
• Uncontrolled diabetes.
• Severe vascular or neurological disease.
• Blood dyscrasias.
• Existing acute or chronic infections, especially at the site of use.
• Metabolic or systemic bone or calcium disorders.
• Severe degenerative bone disease.
• History of radiation to the treatment area.
• History of drug/alcohol abuse.
• History of allergic reactions to PLGA products
• Renal compromised patients.
• Pediatric patients
• Uncooperative patient who will not or cannot follow postoperative instructions,
including individuals who abuse drugs and/or alcohol.
ReOss® is packaged for single use and sterilized by gamma irradiation. Do not resterilize or reuse. The effects of multiple sterilization cycles could cause degradation to the product.
An expiration date is provided with shelf life if package is stored properly and is not damaged or opened. Product(s) must be used prior to expiration date. Inspect product prior to use.
Instructions for Use
These instructions for use of ReOss® are guidelines to be used in conjunction with established surgical techniques. Standard procedures for treatment of bone defects involving bone grafting and internal fixation should be followed. The results of bone grafting procedures are highly variable. When selecting the bone grafting material and the surgical technique to be utilized, the following factors should be taken into consideration:
• Bone quality and location of the defect;
• Anticipated load factor;
• Age of the patient;
• Suitable blood supply at graft site;
• Proper graft apposition;
• Complete coverage of the graft material to maintain material in situ.
For best results, care should be exercised to ensure the correct graft material is selected for the intended application. Radiographic imaging of the defect is recommended to assess the location and extent of the defect to determine the optimum type and amount of ReOss® to be used.
Standard aseptic technique must be maintained to minimize the risk of post-operative complications. Standard postoperative regimen as used when soft tissue and bone augmentation procedures should be followed. All cases must be treated in a manner consistent with individual patient profile, nature and extent of procedure.
Pre-treatment, treatment and post-treatment protocols should be followed as per standard treatment procedures.
Follow established protocols, including pre-and post-medication regimens prescribed to avoid infection, when/where necessary.
Avoid overfilling and do not disturb the material until hardened. Soft tissue flap should approximate in a manner that establishes a tension-free closure of the surgical site.
If using ReOss® at the time of dental implant placement, additional healing time is recommended before loading dental implant.
In the unlikely event of an adverse reaction, report immediately according to established guidelines.
Reprocessing; Cleaning and Sterilization Reusable Stainless Steel Instrumentation
Instructions For Use
Instructions For Use
Instructions For Use
Sales and Technical Service: +1 877-330-0338
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