Basic Information
- Brand Name
- DIO SM-EXTRA WIDE(RBM) IMPLANT SYSTEMS
- Primary DI
- 08806195917626
- Version / Model
- SIT 5202T
- Catalog Number
- SIT 5202T
- Company Name
- DIO Corporation
- Labeler DUNS
- 631085206
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-01-22
- Public Version
- 3
- Public Version Date
- 2022-02-25
- Public Version Status
- Update
- Public Device Record Key
- bfc44b06-0958-4e3d-8a28-f5cf5c4aaeac
- Distribution End Date
- 2022-02-04
Device Description
The DIO SM Implant System is comprised of dental implant, Superstructure, Instruments for prosthetics and Surgical Instruments
The DIO SM Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
The superstructures consist or screws(Closing Screw, Coping Screw), abutments (Screw retained type, Cemented retainde type, Overdenture retainde type), Solid protect cap.
The screws are made of commercial pure titanium, grade 4(ASTM F76) and Ti-6A1-4VELI(ASTM F136) intended to be usedin a narrow tooth gap after implant insertion and to protect exposed top of commercial pure titanium, grade 3 and grade 4(ASTM F76), Ti-6A1-4VELI(ASTM F136), white gold alloy, POM, PMMA. The intentions of each abutment are described in part 2.4. The protect cap is made of POM and intended to protect infecting other substances after solid abutment is fixed on the implant.