Identity
- Trade Name
- DIO SM IMPLANT SYSTEM FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- The DIO SM Implant System is comprised of dental implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO SM Implant System is specially designed for use in dental implant surery. A successfully osseointegrated implant willl achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edendulous mandibles and maxillae, in support of single or multiple-unit restorations. The superstructures consist of screws(Closing Screw, Coping Screw), abutments(Screw retained type, Cemented retained type, Overdenture retained type), Solid protect cap. The screws are made of commercial pure titanium, grade 4(ASTM F67) and Ti-6A1-4VELI(ASTM F136) intended to be used in a narrow tooth gap after implant insertion and to protect exposed top of the implant or to attach the abutment to implant. The abutments are made or commercial pure titanium, grade 3 and grade(ASTM F67), 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. FDA UDI
- Model / Reference
- SAHN 4136 FDA UDI
- Description
- The DIO SM Implant System is comprised of dental implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO SM Implant System is specially designed for use in dental implant surery. A successfully osseointegrated implant willl achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edendulous mandibles and maxillae, in support of single or multiple-unit restorations. The superstructures consist of screws(Closing Screw, Coping Screw), abutments(Screw retained type, Cemented retained type, Overdenture retained type), Solid protect cap. The screws are made of commercial pure titanium, grade 4(ASTM F67) and Ti-6A1-4VELI(ASTM F136) intended to be used in a narrow tooth gap after implant insertion and to protect exposed top of the implant or to attach the abutment to implant. The abutments are made or commercial pure titanium, grade 3 and grade(ASTM F67), 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. FDA UDI
Identifiers
- Catalog Number
- SAHN 4136 FDA UDI
- Primary DI / UDI-DI
- 08806195922323 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dio Sm Implant System by DIO Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- DIO Corporation
Sources (1)
- FDA UDI c77362d0-6925-4c22-a059-277ab809dc75 37 fields · synced Jun 6, 2026