Pilot Drill S-3.3, 2.5/1.8mmDx6.0mmL
by Adin Dental Implant Systems LTD.
Ref GSN0625Model Guided Pilot Drill
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number729010515GuidPilotDrillRJ 07290105152114 | Date20 May 2024 | StatusActive |
| United States | GUDID listing GUDID | Number07290105152114 | Date8 Dec 2020 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Fluted surgical drill bit, reusable
- Model / Reference
- Guided Pilot Drill, GSN0625
- Primary DI / UDI-DI
- 07290105152114
- Basic UDI-DI
- 729010515GuidPilotDrillRJ
- FDA Product Code
- EJL
- EMDN Code
- Z12110102 Dental drills
- GMDN Term
- Fluted surgical drill bit, reusable
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 872.3240
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- IL-MF-000014625
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Adin Dental Implant Systems Ltd.
Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No