Instruction For Use

Dental ImplantSystem

Genxt Dental Implant System is a system of endosseous dental implants made from biocompatible Titanium Alloy (Ti6Al4V) with corresponding abutments, healing abutments, covering and fixing screws, other prosthetic parts and surgical instruments.

Implantation Procedure →
Intended Use
Ti6Al4V

Dental Implant to be placed in bone to support a prosthesis. Teeth • Gums • Maxillofacial

Biocompatible
Titanium Alloy
Endosseous
About

Manufacturer Information

Registered office, manufacturing site and contact details for Genxt Medtech Pvt Ltd.

Manufacturer
Genxt Medtech Pvt Ltd
Registrar Office

Pl.No.11, Nanda Dental Care Bldg., Lane M, Opp. Army Sports Complex, Mundhwa Road, Pune, Pune, Maharashtra, India, 411001.

medtech@genxtimplants.com
Manufacturing Site

Genxt Medtech Pvt Ltd, Plot No 43, S. No.119, Lane No. 8-B, Ramtekdi Industrial Estate, Hadapsar, Pune 411013.

Indication For Use

  • Suitable for replacing individual missing teeth, restoring both function and aesthetics.
  • Implant system excels in replacing multiple missing teeth, offering comprehensive dental restoration solutions.
  • The cause of tooth loss varies and is not restricted unless explicitly contraindicated. Implant selection, irrespective of surgical protocols or tooth location, is the implantologist's prerogative, with manufacturers only specifying contraindications, not indications.

Contraindications

1
Uncontrolled Systemic Diseases

Patients with unmanaged systemic conditions, such as uncontrolled diabetes, may not be suitable candidates due to impaired healing.

2
Inadequate Bone Quantity or Quality

Insufficient bone volume or density in the implant site can hinder successful osseointegration and stability.

3
Active Infection at Implant Site

Presence of an ongoing infection in the oral cavity or at the proposed implant site may compromise the healing process and implant success.

4
Allergies to Implant Materials

Individuals with known allergies to the materials used in the implant should avoid implantation to prevent adverse reactions.

Warnings and Precautions

01

Only trained and experienced dental professionals should perform implant surgeries.

02

Use sterile instruments and aseptic techniques during implantation.

03

Avoid excessive force or torque during implant placement.

04

Monitor patients for any signs of infection, pain, or discomfort during the healing period.

Clinical Guide

Implantation Procedure

1
Step 1

Preoperative Evaluation

  1. 1. Conduct a thorough patient assessment, including a review of medical and dental history.
  2. 2. Assess bone quality and quantity using appropriate diagnostic imaging techniques.
  3. 3. Develop a treatment plan based on the patient's specific needs, including implant type and placement location.
2
Step 2

Surgical Technique

  1. 1.Administer local anesthesia to ensure patient comfort.
  2. 2.Make an aseptic incision at the designated implant site, following sterile procedures.
  3. 3.Prepare the osteotomy site with careful attention to depth and diameter according to the chosen implant size.
  4. 4.Place the Genxt Dental Implant System into the prepared site with precision.
  5. 5.Ensure proper implant alignment and orientation.
  6. 6.Achieve adequate primary stability through controlled torque during placement.
  7. 7.Close the surgical site with appropriate sutures, ensuring proper tissue adaptation.
  8. 8.Provide the patient with postoperative care instructions, including oral hygiene and dietary restrictions.
3
Step 3

Postoperative Care

  1. 1.Advise the patient to maintain excellent oral hygiene to prevent infection.
  2. 2.Schedule regular follow-up appointments to monitor healing and implant stability.
  3. 3.Manage any postoperative complications promptly and appropriately.

Complications and Adverse Reactions

  • Monitor the patient for potential complications such as infection, implant failure, or peri-implantitis.
  • Be vigilant for any adverse reactions, including allergic responses to implant materials.

Maintenance and Follow-up

  • Schedule periodic follow-up visits to assess implant integration and overall oral health.
  • Provide the patient with long-term implant care instructions to ensure longevity and optimal function.

Sterilization and Storage

  • Follow proper sterilization protocols for all implant components.
  • Store implants and associated materials in a controlled, sterile environment.

Disposal

  • Dispose of any unused or expired implants and associated materials in accordance with local regulations.
Reference

Symbols

Manufacturer
Manufacturer
Date of Manufacturer
Date of Manufacturer
Use by Date
Use by Date
Batch Code
Batch Code
Sterilize Use Irradiation
Sterilize Use Irradiation
No Resterilize
No Resterilize
No Reuse
No Reuse
Do not use if package is damaged and consult instructions for use
Do not use if package is damaged and consult instructions for use
Sunlight Away
Sunlight Away
Keep Dry
Keep Dry
Medical Device
Medical Device
Non Pyrogenic
Non Pyrogenic
Caution
Caution
Consult Instruction For Use
Consult Instruction For Use