Identity
- Trade Name
- DIO BIOTITE-H IMPLANT SYSTEMS FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO Biotite-H Implant System`s screw-form dental implant consist of machined titanium. Screw`s Diameter : Ø3.8mm, Ø4.1mm, Ø4.5mm, Ø4.8mm, Ø5.3mm. Length : 8.0mm, 10.0mm 12.0mm, 14.0mm FDA UDI
- Model / Reference
- SAC 5816N FDA UDI
- Description
- The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO Biotite-H Implant System`s screw-form dental implant consist of machined titanium. Screw`s Diameter : Ø3.8mm, Ø4.1mm, Ø4.5mm, Ø4.8mm, Ø5.3mm. Length : 8.0mm, 10.0mm 12.0mm, 14.0mm FDA UDI
Identifiers
- Catalog Number
- SAC 5816N FDA UDI
- Primary DI / UDI-DI
- 08806195923054 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 Biotite-H Implant Systems 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 7c5835ef-f119-46b0-9fcc-db3ddce1a71a 37 fields · synced May 31, 2026