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Drill with Integral Stopper
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref DRIS-380L11Model Drill with Integral Stopper
Identity
- Trade Name
- Drill with Integral Stopper EUDAMEDDitron Dental FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Drill with Integral Stopper L11.5mm Ø3.8mm EUDAMEDFDA UDI
- Model / Reference
- Drill with Integral Stopper EUDAMEDDRIS-380L11 EUDAMEDFDA UDI
- Description
- Drill with Integral Stopper L11.5mm Ø3.8mm FDA UDI
Identifiers
- Catalog Number
- DRIS380L11 FDA UDI
- Primary DI / UDI-DI
- 07290109285252 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290109285252 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 IIa 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
Drill with Integral Stopper by Ditron Dental Ltd — Class IIa — 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-07290109285252 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 e2f66548-3a1b-430d-a6bc-a5d0957b822b 61 fields · synced Jul 25, 2026
- FDA UDI eb603d60-43b8-45bc-971c-aaa7af5122c4 35 fields · synced May 30, 2026