Submerged I Fixture & Abutment
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작성자 최고관리자 작성일 22-08-29 16:25 조회 212회 댓글 0건본문
(1) Product Description
The CSM Submerged Implant System includes various one-stage Fixtures and two-stage Fixtures made of titanium. These implants are surgically inserted into the upper and/or lower jawbone and serve as a tooth root replacement providing a stable foundation for restorations.
(2) Precautions
Surgical technique for endosseous dental ¬fixture implant requires special and complex procedures. Formal training for ¬fixture placement is recommended.
Important : Determine local anatomy and suitability of the available bone for fi¬xture placement. Thorough screening of prospective fixture must be performed. Panoramic and periapical radiograph for visual inspection are essential to determine anatomical landmarks, occlusal condition, periodontal status and adequacy of bone. Lateral cephalometric radiographs, computerized axial tomograghy and tomogram could be instructive. Appropriate radiography, direct palpation and visual inspection of the fi¬xture site are necessary for planning or treatment prior to use fi¬xtures.
(3) Directions for use
The surgical procedure should be done under aseptic condition with specially designed sterile surgical instruments. The sterilized implants have to be delivered precisely from package to preparation site. An electrical surgical drilling system with internal or external irrigation is recommended.
Prescribed drilling sequences (Guide drill – Initial drill – Pre-fi¬nal drill - Final drill – Reamer) or combination of surgical tools. In case of Hard Bone(D1) please use CSM D1 Drill or the drill of next diameter. 70Ncm torque power is recommended and Parallel Pin is used for measuring the direction and the depth of the hole. Fixture in the ampul should be placed up by using Mountless Driver and be planted into the bone. Handpiece or Ratchet Wrench is usable to plant. Insertion depth of CSM fi¬xture shall be 0.2mm below than the bone level. When the fi¬xture is fully seated, carefully remove Mountless Driver and place Cover Screw or Healing Abutment on the ¬fixture. Then close tissue ap and suture it. The healing period will be 45~90days for lower jaw, 90~180days for upper jaw. (Please be careful not to lose balance in drilling work during operation)
(4) Usage and Storage
· This product is disposable. It should not be reused.
· All the product package should be stored at low humidity and room temperature condition
(5) Caution
· Surgical Complications : Implant procedure has risks such as localized swelling, dehiscence, temporary pain, edema, hematoma or bleeding. Numbness of the lower lip and jaw after mandible surgery and tissue beside the nose after maxilla surgery is a possible side-e effect. It is a temporary nature, though the numbness lasts permanently very rarely. Gingival-mucosal (gum tissue) ulceration, tissue reaction, or infection may occur but it generally responds to local care.
· After the procedure of implant treatment could be found swollenness of a speci¬fic part, rupture, temporary palpate sensitiveness, an edema, hematoma, bleeding.
· Insensibility of lower jaw and lip, some side e effects relating around the nose from maxillary sinus treatment may occur that is mostly temporary but rarely permanent paralysis could appear.
· Contraindications : Fixture should not be placed in case where the remaining jaw bone is too diminished to provide adequate width and height to surround the implant. Lack of osseointegration or subsequent implant failure may occur in cases insufficient bone available, poor bone quality, poor oral hygiene, heavy smoking, or under medical conditions such as blood disorders, infected HIV virus or uncontrolled diabetes.
· Warnings (Wornings for possible side e effects from the usage of medical devices) : As fi¬xture surgery and dental restoration involve complex surgical procedures, for safe and e effective use of fi¬xtures, specialized training is strongly suggested. Improper patient selection and technique can cause the fi¬xture failure and/or loss of supporting bone. Wobble of ¬fixture, bone loss, or chronic infection may cause fi¬xture failure. If the ¬fixture becomes contaminated by the patient’s body fluids in any way, the ¬fixture cannot be used in other patient. Do not splint or bridge with natural tooth. Excessive force on the ¬fixture will cause metal fatigue and can cause ¬fixture fracture. Single stand or by ¬fixtures are recommended.
· Interaction : Dental ¬fixtures are designed only for its use and must not be altered and converted in any way. The use of electro-surgical or laser surgical instruments around metallic ¬fixtures and their abutments is not recommended due to the risk of electric shock and/or heat burn.
· Usage for the aged or a pregnant woman : The aged, a pregnant woman, growth phase, an obese patient or a patient who had other case history shall be considered to perform an operation.
· Warnings for application : A surgeon shall be followed instruction of the procedure for high success rate of implant surgery. Advert to not damage on nerves, diagnose concavity on lingual side of the submaxillary bone for preventing perforation of the submaxillary bone. Do not put over torque for preventing bone crack.
· Caution of safety accidents : Take any possible stuff s away as combustibility materials or unsterilization devices from a patient and a surgeon.
■ Suitable location
Use the fi¬xtures as Small[Ø3.5] for incisor(1,2), Narrow[Ø3.8] and Medium[Ø4.2] for canine(3) and premolar(4,5), Regular[Ø4.6] and Wide[Ø5.3] for molar(6)
■ 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.
The CSM Submerged Implant System includes various one-stage Fixtures and two-stage Fixtures made of titanium. These implants are surgically inserted into the upper and/or lower jawbone and serve as a tooth root replacement providing a stable foundation for restorations.
(2) Precautions
Surgical technique for endosseous dental ¬fixture implant requires special and complex procedures. Formal training for ¬fixture placement is recommended.
Important : Determine local anatomy and suitability of the available bone for fi¬xture placement. Thorough screening of prospective fixture must be performed. Panoramic and periapical radiograph for visual inspection are essential to determine anatomical landmarks, occlusal condition, periodontal status and adequacy of bone. Lateral cephalometric radiographs, computerized axial tomograghy and tomogram could be instructive. Appropriate radiography, direct palpation and visual inspection of the fi¬xture site are necessary for planning or treatment prior to use fi¬xtures.
(3) Directions for use
The surgical procedure should be done under aseptic condition with specially designed sterile surgical instruments. The sterilized implants have to be delivered precisely from package to preparation site. An electrical surgical drilling system with internal or external irrigation is recommended.
Prescribed drilling sequences (Guide drill – Initial drill – Pre-fi¬nal drill - Final drill – Reamer) or combination of surgical tools. In case of Hard Bone(D1) please use CSM D1 Drill or the drill of next diameter. 70Ncm torque power is recommended and Parallel Pin is used for measuring the direction and the depth of the hole. Fixture in the ampul should be placed up by using Mountless Driver and be planted into the bone. Handpiece or Ratchet Wrench is usable to plant. Insertion depth of CSM fi¬xture shall be 0.2mm below than the bone level. When the fi¬xture is fully seated, carefully remove Mountless Driver and place Cover Screw or Healing Abutment on the ¬fixture. Then close tissue ap and suture it. The healing period will be 45~90days for lower jaw, 90~180days for upper jaw. (Please be careful not to lose balance in drilling work during operation)
(4) Usage and Storage
· This product is disposable. It should not be reused.
· All the product package should be stored at low humidity and room temperature condition
(5) Caution
· Surgical Complications : Implant procedure has risks such as localized swelling, dehiscence, temporary pain, edema, hematoma or bleeding. Numbness of the lower lip and jaw after mandible surgery and tissue beside the nose after maxilla surgery is a possible side-e effect. It is a temporary nature, though the numbness lasts permanently very rarely. Gingival-mucosal (gum tissue) ulceration, tissue reaction, or infection may occur but it generally responds to local care.
· After the procedure of implant treatment could be found swollenness of a speci¬fic part, rupture, temporary palpate sensitiveness, an edema, hematoma, bleeding.
· Insensibility of lower jaw and lip, some side e effects relating around the nose from maxillary sinus treatment may occur that is mostly temporary but rarely permanent paralysis could appear.
· Contraindications : Fixture should not be placed in case where the remaining jaw bone is too diminished to provide adequate width and height to surround the implant. Lack of osseointegration or subsequent implant failure may occur in cases insufficient bone available, poor bone quality, poor oral hygiene, heavy smoking, or under medical conditions such as blood disorders, infected HIV virus or uncontrolled diabetes.
· Warnings (Wornings for possible side e effects from the usage of medical devices) : As fi¬xture surgery and dental restoration involve complex surgical procedures, for safe and e effective use of fi¬xtures, specialized training is strongly suggested. Improper patient selection and technique can cause the fi¬xture failure and/or loss of supporting bone. Wobble of ¬fixture, bone loss, or chronic infection may cause fi¬xture failure. If the ¬fixture becomes contaminated by the patient’s body fluids in any way, the ¬fixture cannot be used in other patient. Do not splint or bridge with natural tooth. Excessive force on the ¬fixture will cause metal fatigue and can cause ¬fixture fracture. Single stand or by ¬fixtures are recommended.
· Interaction : Dental ¬fixtures are designed only for its use and must not be altered and converted in any way. The use of electro-surgical or laser surgical instruments around metallic ¬fixtures and their abutments is not recommended due to the risk of electric shock and/or heat burn.
· Usage for the aged or a pregnant woman : The aged, a pregnant woman, growth phase, an obese patient or a patient who had other case history shall be considered to perform an operation.
· Warnings for application : A surgeon shall be followed instruction of the procedure for high success rate of implant surgery. Advert to not damage on nerves, diagnose concavity on lingual side of the submaxillary bone for preventing perforation of the submaxillary bone. Do not put over torque for preventing bone crack.
· Caution of safety accidents : Take any possible stuff s away as combustibility materials or unsterilization devices from a patient and a surgeon.
■ Suitable location
Use the fi¬xtures as Small[Ø3.5] for incisor(1,2), Narrow[Ø3.8] and Medium[Ø4.2] for canine(3) and premolar(4,5), Regular[Ø4.6] and Wide[Ø5.3] for molar(6)
■ 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.
