Identity
- Trade Name
- DIO STEADY External Implant System FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units` prosthetic appliance attachment to restore a patient`s chewing function. Implants can be placed with a conventional two stage surgical process with an option for immediate loading. Immediate loading is restricted to the anterior mandible, based on four interforminal placed implants, and not indicated for single unsplinted implants. Patients must be subject for dental treatment with endosseous implants. FDA UDI
- Model / Reference
- ETF 5011R FDA UDI
- Description
- The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units` prosthetic appliance attachment to restore a patient`s chewing function. Implants can be placed with a conventional two stage surgical process with an option for immediate loading. Immediate loading is restricted to the anterior mandible, based on four interforminal placed implants, and not indicated for single unsplinted implants. Patients must be subject for dental treatment with endosseous implants. FDA UDI
Identifiers
- Catalog Number
- ETF 5011R FDA UDI
- Primary DI / UDI-DI
- 18806195920678 FDA UDI
- 510(k) Number
- K100100 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
DIO STEADY External Implant System by DIO Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K100100 also covers:
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 fa034f01-1197-46b1-9b81-ab52d62ee48f 39 fields · synced Jun 1, 2026