DIO Straight Drill
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Straight Drill EUDAMEDDIO Straight Drill FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Multi Initial Drill, Straight Drill, Taper Drill, Taper Stopper Drill EUDAMED
- Model / Reference
- SD 3015 EUDAMEDDIO Implant System Product Catalog Ver 7.0 (KR) EUDAMEDDSU 2010D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800049489659 EUDAMED08800049302545 FDA UDI
- Basic UDI-DI
- 880004926027BR EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4130 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Fixture/appliance dental drill bit, reusable
DIO Straight Drill by DIO Corporation — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fixture/appliance dental drill bit, reusable.
- Hahn — PRISMATIK DENTALCRAFT, INC. · Class I
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
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- Prima Plus — Keystone Dental Inc. · Class I
- Prima — Keystone Dental Inc. · Class I
- Twist Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Stopper Drill — Megagen Implant Co. Ltd · Class I
- Magic Guide Pin — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 f14511fe-1d75-4880-84a0-559941b22167 32 fields · synced Aug 1, 2026
- EUDAMED b77821de-008e-48f1-8407-9cc8f1eb75e5 61 fields · synced Aug 1, 2026