Identity
- Trade Name
- 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 surgery. A successfully ossecintegrated 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. FDA UDI
- Model / Reference
- SFN 3812 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 surgery. A successfully ossecintegrated 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. FDA UDI
Identifiers
- Catalog Number
- SFN 3812 FDA UDI
- Primary DI / UDI-DI
- 08806195921814 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 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
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 9cf9aa5e-6093-4118-a99e-b9a32167e661 38 fields · synced Jun 8, 2026