ST Internal Fixture System

Fixture
1. Product Summary
This product is a dental implant, which is made of pure titanium, and is implanted into a mandible (the lower jaw bone), or a maxillary jaw bone (the upper bone) as a root of the tooth through the surgical operation by the dentist to restore a chewing function of partially or fully edentulous patients. There are various sizes and shapes to implant into the anterior or posterior site for different conditions of dental loss.
2. Indication for Use
Dental medical device, which is implanted in the upper or lower jaw bone to support prosthetic device such as dental prosthesis, to restore a chewing function of partially or fully edentulous patients
3. Instruction for Use & Procedure
(1) Pre-operative planning
For a successful treatment, the following confirmation procedures should be performed carefully to confirm the treatment plan and evaluation, and also the product with medical and dentistry’ point of view.
  • Should check out the patient’s oral status through the clinical, radiography photo, and model analysis.
  • Should ask the patient’s decision in case of various treatment methods, after providing the sufficient explanation of the merit and demerit of each method and treatment schedule.
  • Should check a patient’s medical history to evaluate the status of patient’s health condition. If there is any doubt about a patient’s health condition, the various clinical tests should be performed to determine the absence of abnormal conditions before preparing for the surgery.
  • Should check the sealing condition of the packaging, which is completely sterilized by gamma-irradiation, to ensure that the product is completely sealed and remains the sterilization status.
  • Should not use the product if the package is not completely sealed or that is torn, and also should certainly check the abnormalities such as foreign body, stain, minute dust, and etc. after opening the package.
(2) Applications
The following explains roughly how to use and operate the product. For a detailed procedure, please refer to the catalog of relevant Implant System issued by T-Plus Implant Tech. Co., Ltd.
  • Drill into the alveolar bone in order to place an implant fixture into the planned location with various surgical instruments. At this time, revolutions per minute (RPM) of the drill should be adjusted according to the condition of the bone and the kinds of surgical instruments. Irrigate sufficiently the saline solution onto the area to prevent the necrosis of bone by heat.
  • After making an appropriate hole for a fixture, confirm the kinds of fixture and size described on the label, and take out the transparent plastic container included ampule from the exterior box.
  • Clasp the convex part downwardly directed of transparent plastic container by one hand. Then hold the arrow mark on the label sticker by another hand and take a medical paper off slowly to open the plastic container. After that, take out the sealed ampule.
  • The cap on the ampule is designed as a “Snap-on” type, which can be easily opened by one-hand and one touch. Clasp the ampule by one hand and then push the cap up by the thumb to separate the cap from the ampule at a time.
  • Check whether the fixture is fixed on a Holder (holder type) or a Titanium leveler (leveler type). For holder type, check the Mount is connected with the fixture. For leveler type, check the Mount is not connected with the fixture. In case the fixture is external type and not connected with the Mount, you should connect the Mount to the fixture.
  • Take out carefully the fixture from the ampule by connecting Handpiece Connector to the fixture or Mount.
  • Position the fixture near the drilled site paying attention during movement that the fixture does not separate from Handpiece Connector & does not become contaminated by foreign bodies.
  • A fixture is implanted into the bone to planned depth by turning(15~30rpm) a Handpiece clockwise with 40-45Ncm torque.
  • If the fixture is not completely implanted into the bone due to the hard bone density, separate Handpiece Connector from the fixture, then finish implanting by using a Ratchet Wrench.
    *In the case of using Ratchet Wrench, it may happen to some possibility of surgical failure due to the structure deformation of inside of fixture by excessive torque. Therefore, the torque under 80Ncm is recommended.
  • After implantation of the fixture, finish the operation by connecting Cover Screw to the fixture with torque under 10Ncm by using Hand Driver to protect the inside of fixture from the foreign bodies, and then suture the surgical site.
(3) Post-operative care
  • After surgery, the healing period depends on each patient’s clinical condition (bone quality, bone quantity, initial stability, loading condition, etc.). Therefore the careful attention of patient and clinician's close inspection on the progress are needed.
  • Give advice to the patient for recognizing that excessive pressure such as masticatory force is not applied to the surgical site during the healing period (Osseo-integration period).
  • Give advice to the patient for taking good care of the patient's oral hygiene to avoid side effects.
  • Attach the identification tag containing the Lot number, which is enclosed in the exterior box, on the patient’s chart, x-ray film, etc. to make it possible to trace the product.
  • Before operating the next stage of surgery, the clinician should check the fixture's progress of Osseo-integration by x-ray image or diagnosis such as percussion reaction.
4. Adverse Effects
  • It could result in implantation failure, like bone loss, low initial stability, fixation failure, irritation and nerve damage.
  • Complications such as edema, hematoma, swellings, ruptures, bleeding, infection, soft tissue ulcer and an open suture site may result from inattentive surgical practice or poor patient overall health.
  • Numbness from nerve damage in the facial area is usually a temporary symptom, but some cases are permanent.
5. Contraindication
Contraindications should be observed when selecting patients. These include, but are not limited to:
  • Low bone quality and inadequate bone quantity
  • Bad oral hygiene and pathological infection at the alveolar bone.
  • Internal diseases such as hematodyscrasia and diabetes, or malnutrition.
  • Alcoholic, drug abuse, heavy smoking and a mental patient.
  • Other periodontal and surgical operation prohibited patient.
6. Preservation & Handling
  • The package hermetically sealed and sterilized with gamma radiation should be stored at low humidity and room temperature condition.
  • The product must be opened just prior to surgery.
  • Surgical instruments verified for safety as a medical device should be used.
  • Unpacked or damaged product should be not used and it cannot be returned to the manufacturer or distributor.
7. Caution
  • Be fully aware of the instructions for use prior to using T-Plus Implant System.
  • Do not use the product, if the valid date (shelf life) were expired.
  • Do not use the product contaminated by mistake of the operating surgeon.
*Warnings
  • Dental surgery must only be performed by dentists and surgeons with training and experience in oral surgery as well as diagnosis and preoperative planning.
  • The product must be used in clean area.
  • Inappropriate selection of patient and surgery can cause the implantation failure and loss of alveolar bone.
  • This is a single-use product and should not be reused.
  • Risks re-using single-use medical device
    • Re-use is not validated and it carries risks such as transmission of infectious diseases.
    • It could be resulted in extensive malfunctions, including the defective connection, jammed abutment, damage, and screw loosening.
    • Failure of osseo-integration may occur.
  • The manufacturer does not have any responsibility for the product re-sterilized by users.
Prosthesis
1. Product Summary
To recover a patient’s masticatory function, it is necessary to have a dental implant which is implanted into a patient’s alveolar bone as a root of a tooth and abutment which is protruded through the gum in the oral cavity. These products include various Implant Component Systems to offer a masticatory function and esthetic result very similar to natural tooth.
2. Indication for Use
  • T-Plus Implant Component Systems are used to fabricate appropriate prosthetic restorations correspond to fixture implanted in the alveolar bone.
  • These products include various sizes and shapes to select according to intended use and its use.
  • Product lines are as follows:
    • Products for healing or formation of soft tissue
    • Products for fabricating of final prosthesis
    • Products for fabricating of provisional prosthesis
    • Products for impression taking
    • Products for interconnection of prosthesis
3. Instruction for Use & Procedure
For detailed procedure, please refer to the catalog of relevant Implant System issued by T-Plus Implant Tech. Co. Ltd.
4. Contraindications
To have a successful implant surgery, it is necessary to meet a standard condition. Low quality bone, inappropriate bone, poor oral hygienic condition, internal diseases such as blood disease and diabetes, excessive smoking, and etc. can be the reason for failure of surgery or osseointegration.
5. Warning
The following is strongly recommended for safe and effective use of T-Plus Implant Component System.
  • The surgeon should be a medical specialist who practiced high technique for implant surgery.
  • The surgeon should be fully aware of the operating method and cautions for the product before the use.
  • The surgeon should wear an aseptic operating gown, and perform surgery in the operating room remained the aseptic condition during surgery.
  • Inappropriate selection of patient and technique can cause a failure of the implant surgery and loss of supportive bone.
  • Risks associated with the reuse of single-use medical device: A single-use medical device is not validated for reuse. Reuse of single-use medical devices carries risks such as transmission of serious infectious disease or malfunction of the reused devices.
6. Precaution
A patient to be operated and the product to be used should be thoroughly examined before surgery.
  • he visualization of anatomical boundary, occlusal condition, periodontal condition, bone volumes, and etc. should check through visible examinations such as panoramic images and periapical radiographs.
  • Side cephalometric radiograph, CT image, and tomogram may be useful.
  • After opening the packaging, the product should be checked for abnormalities and contaminants.
  • The surgeon should advice for the patient to devoid that excessive pressure such masticatory force is applied to the surgical site during the healing period.
7. Adverse Effects
The following may occur after surgery; poor initial stability of implant, failure of osseointegration, or other side effects from an inappropriate prosthetics. The low level and quality of the residual bone, infection, a patient’s poor oral hygienic conditions, generalized disease(e.g. diabetes, etc.) can be the reason for the surgery failure in some patients.
8. Surgical Complications
  • The swelling of specific parts, rupture, temporary palpate sensitiveness, edema, hematoma, and bleeding symptom may occur due to the danger of implant surgery.
  • The insensibility of the jaw part and under lip from mandible surgery, and of the side part of nose tissue from maxilla surgery may occur. Most of cases are temporary but in unusual cases, permanent paralysis may occur.
  • The mucogingival ulcer, cell tissue reaction or infection may occur, but generally they are accompanied reaction caused by the local treatment.
9. Handling
  • Cover Screw and Healing Screw are products sterilized by gamma-irradiation.
  • Non-sterilized products should be sterilized with high pressure steam sterilization for 22 minutes at temperatures 121℃(249.8℉) before use.
  • Products made of plastic may deform in process of high pressure steam sterilization, therefore should not exceed 160℃ or pressure 0.45MPa.
  • After applying the investment, cool the investment slowly for coagulation to avoid the deformation by the delicate shrinking or expansion.
  • It should be used surgical instruments of relevant Implant system.
  • For tightening, should use recommended torque value.
  • Melting temperature for gold materials: above 1481.5˚C
  • Burnout temperature for plastic materials: above 332˚C
10. Caution
  • Product should not be used if packaging is opened or damaged.
  • Do not use the contaminated product by mistake of surgeon during the surgery.
  • The product is a single-use product, therefore it should not be reused.
Manufacture: T-Plus Implant Tech. Co., Ltd.
No.41, Wuquan 6th Rd., Wugu Dist., New Taipei City 248, Taiwan (R.O.C.)