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Internal Fixture & Abutment > e-IFU

e-IFU

Internal Fixture & Abutment

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작성자 최고관리자 작성일 22-08-29 16:25 조회 210회 댓글 0건

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(1) Product description
The CSM Implant System includes a various type and sizes of precision-machined ¬fixtures manufactured from grade Ⅳ titanium. These implants are surgically inserted into the upper and/of lower jawbone and serve as a substitute or replacement tooth root providing a stable foundation for restorations.

(2) Indications for Use
CSM Implant systems are designed for use in dental implant Surgery. A successfully Osseointegrated ¬fixture will achieve a ¬rm and direct connection between the living bone and the surface of the titanium fi¬xture when surgically fi¬xture under controlled conditions. There are intended for use in partially or fully edentulous mandibles and maxillae, to support for single or multiple-unit restorations such as cemented retained, screw retained, or over denture restorations, and terminal or intermediate abutment support for ¬fixed bridgework.

(3) Directions for Use
The surgical procedure should be done under aseptic condition with specifi¬cally designed sterile surgical instruments. The ¬fixture provides precise placement of sterile threaded fi¬xtures form package to preparation site. An electrical surgical drilling system with internal and external irrigation is recommended for drilling the surgical site. Specifi¬c drilling sequences for placement of ¬fixtures should be followed (ref.catalogue).You should use the tap if it is a high density bone(D1,D2). When drilling with countersinks, pilot, depth gauges and fi¬nishing drills, use with in-and-out motion. The use of a surgical guide, a depth gauge and parallel pins, is recommended to aid in fi¬xture placement. The fi¬xture would be installed into the prepared site with the surgical ratchet or handpiece adapter to the attached placement head. Continue put the ¬fixture into the site in a clockwise direction until fully seated.
Remove the placement head and place the cover screw to the top of the ¬xture. Close and suture the tissue flap.

(4) Contraindications
CSM ¬fixtures should not be placed in cases where the remaining jaw bone is too diminished to provide adequate width or height to surround the fi¬xture. Lack of osseointgration or subsequent -fixture failure may occur in cases where there is insufficient available bone, poor bone quality, poor oral hygiene, heavy smoking or tobacco abuse, or medical conditions such as blood disorders or uncontrolled diabetes. Lack of general contraindications associated with general surgery should be observed. Possible contraindications; Chronic bleeding problems; psychological impairment;
metalbolic bone or connective tissue diseases; treatment with corticosteroids; certain cardiac and vascular diseases; tobacco usage; diabetes (uncontrolled); treatment with chemotherapeutic agents; chronic renal diseases; poor patient oral hygiene bruxing; alcoholism. Relative contraindications; Systemic infection; local oral or respiratory infection.
Anatomical or pathological, contraindications; Insufficient alveolar bone width and height to surround the ¬fixture with at least one millimeter of bone. Both buccally and lingually to the most superior aspect of the fi¬xture placement would encroach of the mandibular canal; malignancies.

(5) Warning
Fixture surgery and restoration involve complex dental procedures. For safe and e effective use of CSM ¬fixtures, it is strongly suggested that specialized training be undertaken since the surgical techniques required to place dental fi¬xtures are highly specialized and complex procedures. Improper patient selection and technique can contribute to ¬fixture failure and/or loss of supporting bone. CSM fi¬xtures are intended for use only in the indicated applications. Dental ¬fixtures must not be altered in any way.
The use of electro-surgical instruments or lasers around metallic ¬fixtures and their abutments is not recommended due to the risk of electric and/or heat conductivity. Fixture mobility, one loss, or chronic infection may indicate fi¬xture failure. If the fi¬xture becomes contaminated by the patient’s body fluids in any way, the fi¬xture cannot be used in any other patient.

(6) Sterilization and Handling
Sterile package containing the fi¬xture, fi¬xture mount and cover screw have been cleaned and sterilized by gamma irradiation and are ready to use.
That should be opened onto a sterile fi¬eld and handled with titanium instrumentation only. Do not re-sterilized. Do not use if package is opened, damaged, or expired. Discard open, unused product.
 
(7) Caution
① Because all components are sterilized by gamma-radiation it should be used immediately after unpacking. Do not reuse.
② Especially in molar region, do not use a ¬fixture alone, install at least 2 fi¬xtures together.

(8) Precautions
Through screening of prospective fi¬xture candidates must be performed. The surgical techniques required to place endosseous dental ¬fixtures require specialized and complex procedures. Formal training for placement of ¬fixtures is recommended.
Important; Determine local anatomy and suitability of the available bone for fi¬xture placement. Visual inspection as well as panoramic and periapical radiographs are essential to determine anatomical landmarks, occlusal conditions, periodontal status, and adequacy of bone. Lateral cephalometric radiographs, CT scans, and tomograms may also be bene¬ficial, adequate radiographs, direct palpation, and visual inspection of the ¬fixture site are necessary prior to treatment, planning, and use of CSM ¬fixtures.
 
■ This product is for dental surgery
■ Do not reuse

■ Waste Management
 Fixtures, Abutments and Drills stained with blood and saliva are classified as infectious waste and must be disposed of according to the guidelines for discharging medical waste. Packaging materials and containers should be classified as general waste and discharged separately to prevent an unnecessary increase in medical waste due to mixed discharge.

■ Website
 Product-related information (including clinical data) and e-IFU can be found at "http://csmimaplant.com".

■ Copy Request
 Where multiple devices are provided for a single user and/or location, a single copy of the Instructions for Use may be provided with Buyer's consent, and Buyer may request additional copies, free of charge, in any case.

■ Material Used
The product is made of Titanium Grade 4. (Abutment)
The product is made of Titanium Grade 23 Ti-6Al-4V Eli. (Fixture)
The product is made of UNS S42010 Stainless Steel. (Drill)

■ Incident Management
All serious accidents involving the device must be reported to the competent authorities of the Member State where the manufacturer, user and patient are located.
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