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FTN Fixture Driver
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DIO Implant System Product Catalog Ver 7.0 (KR)Model MRHSB 4805
Identity
- Trade Name
- FTN Fixture Driver EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- UniCon Abutment Protect Cap, UniCon Abutment Impression Cap, UniCon Pick up Impression Coping, UniCon Transfer Impression Coping, UniCon Abutment Lab Analog, FTN Fixture Driver, Initial Check Pin, Fixture Driver, and 39 additional item EUDAMED
- Model / Reference
- MRHSB 4805 EUDAMEDDIO Implant System Product Catalog Ver 7.0 (KR) EUDAMEDHGC 5020 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800049309193 EUDAMED08800049308875 FDA UDI
- Basic UDI-DI
- 880004921003A8 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical screwdriver, reusable
FTN Fixture Driver by DIO Corporation — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, reusable.
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- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DIO Corporation
Sources (2)
- FDA UDI a125c837-069e-4f95-bde8-90835f620fce 32 fields · synced Jul 9, 2026
- EUDAMED 9346b205-33b8-41bd-8001-b0e18694483f 61 fields · synced Jul 9, 2026