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Drill S-5.5, 4.6/3.85mmDx11.5mmL
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GS1146Model Guided Drills_2
Identity
- Trade Name
- Drill S-5.5, 4.6/3.85mmDx11.5mmL EUDAMEDFDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Model / Reference
- Guided Drills_2 EUDAMEDGS1146 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109300160 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010930GuidDrill4C EUDAMED
- FDA Product Code
- EJL FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3240 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
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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Drill S-5.5, 4.6/3.85mmDx11.5mmL by Adin Dental Implant Systems Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 729010930GuidDrill4C | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Adin Dental Implant Systems LTD.
- EUDAMED SRN
- IL-MF-000014625
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 4562ab36-699a-416a-8a9a-207188223a46 61 fields · synced Jul 24, 2026
- FDA UDI d222a1f2-123f-4d12-b16b-edf90a89c1fd 32 fields · synced May 30, 2026