Identity
- Trade Name
- DIO Implant Systems FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These implants are surgically inserted into the upper and/or lower jawbone, and serve as a substitute or replacement tooth root providing a stable foundation for restorations. FDA UDI
- Model / Reference
- FSN 3310B FDA UDI
- Description
- The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These implants are surgically inserted into the upper and/or lower jawbone, and serve as a substitute or replacement tooth root providing a stable foundation for restorations. FDA UDI
Identifiers
- Catalog Number
- FSN 3310B FDA UDI
- Primary DI / UDI-DI
- 08806195936221 FDA UDI
- 510(k) Number
- K070570 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 Implant Systems by DIO Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K070570 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 ff1f4942-40c7-44d1-96dc-6f6859124e9b 38 fields · synced Jun 8, 2026