Drill S-5.5, 4.6/3.85mmDx18.0mmL GS1846
by Adin Dental Implant Systems Ltd
Ref GS1846Model Guided Drills_2
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 | Number729010930GuidDrill4C 07290109301945 | Date20 May 2024 | StatusActive |
| United States | GUDID listing GUDID | Number07290109301945 | Date11 Apr 2021 | 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- Withdrawn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
- Trade Name
- Drill S-5.5, 4.6/3.85mmDx18.0mmL
- Generic Name
- Fluted surgical drill bit, reusable
- Model / Reference
- GS1846, Guided Drills_2
- Primary DI / UDI-DI
- 07290109301945
- Basic UDI-DI
- 729010930GuidDrill4C
- 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 |
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