[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.
[Product 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 fixture 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 fixture site are necessary for planning or treatment prior to use fixtures.
[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-final 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 fixture shall be 0.2mm below than the bone level.
· When the fixture is fully seated, carefully remove Mountless Driver and place Cover Screw or Healing Abutment on the fixture.
· Then close tissue flap 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)
[Product Specification]
· CSM dental implant is used to restore lost chewing ability and improve aesthetics by replacing missing tooth roots of edentulous patients.
· Submerged Implant
(Sub1, Sub3: abutment could be comaptible with Osstem-TS, Dentium-Super line, Implantium More than 90% CSM customers are using this system)
· Surgical kit: All the drills and drivers have duration for 30~50 times.
· Qualification: ISO13485, CE mark, Korea KFDA, USA FDA, CFDA Certificate approval
[Surface treatment]
1. RBM surface: It is most common surface among the implant manufacturers. The surface is treated by HA powder.
- Reference: https://synapse.koreamed.org/DOIx.php?id=10.4047/jkap.2018.56.1.1&vmode=PUBREADER
2. SLA surface: https://www.ncbi.nlm.nih.gov/pubmed/27540839
3. Laser surface:
Comparing with anodized
https://www.ncbi.nlm.nih.gov/pubmed/21778844
Comparing with SLA
https://synapse.koreamed.org/Synapse/Data/PDFData/0170JAP/jap-6-302.pdf
https://www.ncbi.nlm.nih.gov/pubmed/25177474
Comparing with Active SLA
https://synapse.koreamed.org/Synapse/Data/PDFData/0170JAP/jap-8-110.pdf
https://www.ncbi.nlm.nih.gov/pubmed/27093590
Clinical Studying
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5917109/pdf/jap-10-163.pdf
https://www.ncbi.nlm.nih.gov/pubmed/29713438
You can find further details on our web-site www.csmimplant.com