Instruction for Use(Dental Implant Abutment)
1. Purpose of Use
The upper structure of the implant is inserted to suppoert prosthetic appliances such as
artificial teech used to recover the masticatory function of the patient.
2. How to Use
1) Preparations before Use
➀ The clinician should completely understand the performance and func-tion of this product before usage.
Therefore, explain the limit of the implant to the patient, who should clearty recognize the function of the implant and aesthetic limit.
➁ If you have questions about this product before use, contact All Abutment and make an inquiry.
➂ When selecting an abutment you should prepare a plan based on the inspection of the oral health
status of the patient and make exact judg-ment in advance.
➃ Prepare a proper driver for abutment fastening.
➄ Precautionary step should be taken to prevent swallowing or intake of the product
by patients who lack understanding of the product
➅ Since this is a non-sterilized medical device you should sterilize it through autoclave
at 132 ℃ and pressure of 1.5 for 15minutes before use.
Condition
| Temperature | Exposing Time | Dry Time |
Gravity | 132℃(270℉) | 15 min | 30 min |
Pre Vacuum | 4 min |
2) Surgery Method
➀ Select an abutment that is appropriate for the oral environment for the fixture through
which osseointegration has beensuccessfully realized.
➁ Install a driver in the abutment and fasten it to the fixture. The recommended fastening
torque is 30Ncm in general.
➂ Make a dental technical model based on the impression techniques and fabricate the prosthesis
considering occlusion, intensity,and aesthetics.
➃ Finish the surgery bo modifying the prosthesis based on the occlusion and the patient’s foreign body
sensation following the installation of prosthesis after removing the healing abutment and checking the oral abutment state.
3) Maintenance after Use
Since this product is a single-ues Medical device. reuse is prohibited
3. Cautions in Use
1) Warning
➀ Since product damage and surrounding bone tissue damage can occur, the product should be used only by an experienced clinician.
➁ This product should not be reused and should be applied according to the correct use and purpose.
➂ Defective products should be returned.
➃ This product should be handled carefully to prevent production damage and deformation.
2) General Cautions
➀ When operating the abutment in the intraoral area, the operator should perform surgery after checking the degree
of osseointegration of the placed fixture through radiography or precussion whitout failure.
➁ The product should not be used if contaminated by mistake of the operator during operation.
➂ Since all products that are used in the intraoral area are single-use products.
➃ Implant surgery should be reconsidered when patients have contraindication.
3) Cautions on application
➀ Since the abutment is a non-sterilized medical device, you should sterilize it through autoclave at 132 ℃
and pressure of 1.5 for 15minutes before use
➁ When fastening the abutment to the fixture, use a driver suitable for the specification of the abutment
4. Storage Method
➀ Store at room temperature.
AA-IFU-02 09/2023 REV.00
