Instructions For Use (IFU)
COWELL® INNO Implant System - Fixture
Doc. No.: CWM-CE-IFU-F01 Rev. No.: 1 Issued date: 2020-01-08
Cowellmedi Co., Ltd. 48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, 46986, Republic of Korea z TEL : +82-51-314-2028 FAX:+82-51-314-2026, www.cowellmedi.com
Instructions for Use
1. Device Description
The Cowellmedi implant system includes a variety of precision-machined fixtures manufactured from titanium. These implants are surgically inserted into a mandible (the lower jawbone) or a maxillary bone (the upper jawbone) and replace the patient's tooth root, providing a stable foundation for restoration.
2. Intended Use
To support dental prosthesis, this dental device is implanted into the alveolar bone to restore the masticatory function and for better aesthetics in patients with partially or full edentulous jaws
3. Directions for Use
1) Surgery –The first stage
a. According to the patient's condition, appropriate dental cleaning operations may be performed and preventive antibiotics may be administered before the implant operation.
b. Clean and disinfect the operative site, administer local anesthesia in the area, and expose the alveolar bone by making appropriate incisions and reflecting the gingival tissues along the alveolar crest in the area from where the teeth were extracted.
c. Drill into the gum to implant the fixture into the planed place with various dental operation tools. The speed of the revolution of the drill should be adjusted based on the condition of the bone and the kinds of operation tools used. Saline solution should be poured onto the area to prevent necrosis from bone heating. (The drilling speed should be less than 1,200 rpm.)
d. Remove the external sterile package cover sheet, open the cap of the ampule, affix the fixture driver (for a no-mount fixture) or the mount driver (for a pre-mounted fixture) to the handpiece and connect it to the fixture, move the assembled piece to the osteotomy site for the implant, while taking care not to separate the assembled piece or contaminate it with foreign materials.
e. Implant the fixture into the bone with the planned depth by turning (at 25-30 rpm) the handpiece clockwise with 15-50N.cm torque. If it is difficult to insert, extend the width of the bone with a tap drill or a countersink to facilitate better implantation.
f. After finishing the implantation, suture the treated part with a hex driver to connect it to the cover screw with 5N.cm torque, so as to prevent the intrusion of a foreign substance in the fixture.
2) Surgery –The second stage
a. Incise the gingival on the upper part of the fixture after the bone fusion and remove the cover screw, tighten the healing abutment, and start the gingival curing for the prosthesis.
b. In general, perform the surgery with a prosthesis method.
4. Contraindications
The operation should be reconsidered when the patient has any of the following conditions. COWELL® INNO Implant System - Fixture
Doc. No.: CWM-CE-IFU-F01 Rev. No.: 1 Issued date: 2020-01-08
Cowellmedi Co., Ltd. 48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, 46986, Republic of Korea z TEL : +82-51-314-2028 FAX:+82-51-314-2026, www.cowellmedi.com
a. Oral infection or inflammation
b. Low-quality bone that will result in an unstable implant
c. A drinking problem or mental disease, or a history of substance or medicine abuse
d. An internal disease such as hematodyscrasia or diabetes, and undernourishment
e. Any other condition that will make the patient unsuitable for the operation
5. Warnings
Implant surgery and restoration involves complex dental procedures. For safe and effective use of Cowellmedi fixtures, it is strongly suggested that specialized training be undertaken, since the surgical techniques required to place dental implants are highly specialized and complex. Improper patient selection and technique can contribute to fixture failure and/or loss of the supporting bone.
Cowellmedi fixtures 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 shock and/or burns.
Fixture mobility, bone loss, or chronic infection may indicate fixture failure.
The treatment should be done in an aseptic condition by an operator wearing an aseptic costume. If the fixture is contaminated by the patient's body fluids in any way, it cannot be used in any other patient.
6. Precautions
The surgical techniques required to place endosseous dental fixtures involve specialized and complex procedures. Thus, formal training for placement of fixtures is recommended. Important: Determine the local anatomy and suitability of the available bone for the fixture placement. Fixture candidates must be thoroughly screened. Visual inspection as well as panoramic and periapical radiographs are essential to determine anatomical landmarks, occlusal conditions, the periodontal status, and the adequacy of the bone. Lateral cephalometric radiographs, CT scans, and tomograms may also be beneficial. Adequate radiographs, direct palpation, and visual inspection of the fixture site are necessary before the use of Cowellmedi fixtures.
7. Adverse effects
Complications (loss of fixture anchorage, prosthesis, etc.) may occur after the surgery. An insufficient quantity or poor quality of the remaining bone, infections, poor patient oral hygiene or cooperation, patient discomfort, fixture mobility, local soft tissue degeneration, and unfavorable fixture placement or alignment are some potential causes of loss of anchorage.
8. Surgical Complications
The implant procedure has risks, including localized swelling, dehiscence, tenderness of short duration, edema, COWELL® INNO Implant System - Fixture
Doc. No.: CWM-CE-IFU-F01 Rev. No.: 1 Issued date: 2020-01-08
Cowellmedi Co., Ltd. 48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, 46986, Republic of Korea z TEL : +82-51-314-2028 FAX:+82-51-314-2026, www.cowellmedi.com
hematoma, and bleeding.
Numbness of the lower lip and chin region may occur after lower jaw surgery, as can numbness of the tissue beside the nose after upper jaw surgery.
Though such numbness is likely to be temporary, in very rare cases, it became permanent.
Gingival-mucosal (gum tissue) ulceration, tissue reaction, or infection may occur, but these generally respond to local care.
9. Post-implant Management
a. The upper jaw requires a healing period of 6-8 months depending on the bone quality, and the lower jaw requires a healing period of 3-5 months, again depending on the bone quality. If pressure is applied to the fixture during the healing period, such as in mastication, early fixation may not be achieved or osseointegration of the fixture may not occur within the healing period.
b. Once the operator clinically determines that sufficient osseointegration has been achieved, he/she should begin producing the dental prosthesis.
c. The Lot Number Identification Tag and the X-ray film should be attached to the patient's chart, to track the product when needed.
d. The operator should determine the osseointegration status of the implant through X-ray and clinical methods such as percussion and/or reverse torqueing
10. Storage / Sterilization and Handling
a. Store the product at room temperature and in a dry place.
b. The fixture, fixture mount, and cover screw have been cleaned and sterilized through radiation (gamma irradiation) and are ready for use.
c. The product packages should be opened just before their use during the operation. Expired products should not be used.
d. Only appropriate sterilized surgical tools made specifically for dental implants should be used during the operation.
11. Expiration Date
The expiration date of the product is 5 years from its manufacture.
12. Cleaning & Sterilization
Non-sterilized surgical instruments should be cleaned according to current standard dental practices.
Select a suitable method of cleaning that removes all visible contaminants from the product in sterilized and distilled water.
After the cleaning, package the product appropriately and sterilize it via autoclaving at the minimum condition of 250°F (121°C/15 min).
13. Caution
a. As this product has been sterilized through gamma radiation, it should not be used under any circumstances if the COWELL® INNO Implant System - Fixture
Doc. No.: CWM-CE-IFU-F01 Rev. No.: 1 Issued date: 2020-01-08
Cowellmedi Co., Ltd. 48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, 46986, Republic of Korea z TEL : +82-51-314-2028 FAX:+82-51-314-2026, www.cowellmedi.com
package is open when the product is first received.
b. This product is disposable. It should not be reused
14. Disposal
Treat used fixture as a biohazard and dispose of under facility policy for contaminated items when disposing.
* Note : Any serious incident that has occurred in relation to the COWELL® Implant System - Fixture should be reported to the Cowellmedi Co., Ltd. and the competent authority of the Member State in which the user and/or patient is established.
Manufacturer : Cowellmedi Co.,Ltd
48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, 46986, Republic of Korea
TEL : +82-51-314-2028 FAX:+82-51-314-2026
Certification Experts B.V.
Amerlandseweg 7, 3621 ZC, Breukelen, The Netherlands
Rx Only
(For USA Only)
|
Caution: Federal law restricts this device to sale by or on the order of a dentist KR: CE 제품인증마크 EN: CE Mark |
KR: 모델명, 카탈로그번호 EN: Catalogue number |
|
KR: 방사선멸균 EN: Sterilized using irradiation |
KR: 배치(batch)코드 EN: Batch code |
|
KR: EO 멸균 EN: Sterilized using Ethylene Oxide |
KR: 사용설명서참조 EN: Consult instructions for use |
|
KR: 비멸균 EN:Non-sterile |
KR: 재사용불가 EN:Do not re-use |
|
KR: 주의 EN:Caution |
KR: 제조업자 EN: Manufacturer |
|
KR: 유효기간 EN: Use by date |
KR: 제조일자 EN: Date of manufacture |
|
KR: 유럽대리인 EN: Authorized representative in European community |
KR: 온도제한 EN: Temperature limitation |