Identity
- Trade Name
- Twist drill EUDAMEDDitron Dental FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Twist Drill Ø3.8mm EUDAMEDFDA UDI
- Model / Reference
- Twist drill EUDAMEDDRT38-300438 EUDAMEDFDA UDI
- Description
- Twist Drill Ø3.8mm FDA UDI
Identifiers
- Catalog Number
- DRT38-300438 FDA UDI
- Primary DI / UDI-DI
- 07290109285405 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290109285405 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Twist drill by Ditron Dental Ltd — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07290109285405 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Ditron Dental Ltd.
- EUDAMED SRN
- IL-MF-000015966
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (2)
- EUDAMED 4b9108dd-6625-4592-8668-845a9af9690a 61 fields · synced Jun 19, 2026
- FDA UDI 87ac6c99-9e0c-4417-8ab4-3443d153a77e 35 fields · synced May 30, 2026