TS Bite Impression Coping Driver OICDMH
by OSSTEM IMPLANT Co., Ltd. 2 variants
Ref GSBICR5540H, GSBICR4630H, GSBICM4560H, GSBICR5560H, GSBICR4461H, GSBICR4650H, GSBICM4460H, GSBICM4660H, GSBICR5460H, GSBICR4541H, GSBICM4531H, GSBICM4530H, GSBICM4521H, GSBICR5530H, GSBICR4520H, GSBICM4541H, GSBICR4561H, GSBICM4461H, GSBICM4561H, GSBICR4551H, GSBICM4520H, GSBICM4661H, GSBICR4530H, GSBICR4560H, GSBICR5550H, GSBICR4460H
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 | Number88000406CLASSIBUSANHY | Date11 Feb 2026 | StatusActive |
| United States | GUDID listing GUDID | Number08809892344023 | Date8 Dec 2022 | 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- Withdrawn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
- TS Bite Impression Coping EUDAMEDTS Bite Impression Coping Driver GUDID
- Generic Name
- Surgical screwdriver, reusable
- Device Name
- Impression Tool System
- Model / Reference
- GSBICR5540H EUDAMEDGSBICR4630H EUDAMEDGSBICM4560H EUDAMEDGSBICR5560H EUDAMEDGSBICR4461H EUDAMEDGSBICR4650H EUDAMEDGSBICM4460H EUDAMEDGSBICM4660H EUDAMEDGSBICR5460H EUDAMEDGSBICR4541H EUDAMEDGSBICM4531H EUDAMEDGSBICM4530H EUDAMEDGSBICM4521H EUDAMEDGSBICR5530H EUDAMEDGSBICR4520H EUDAMEDGSBICM4541H EUDAMEDGSBICR4561H EUDAMEDGSBICM4461H EUDAMEDGSBICM4561H EUDAMEDGSBICR4551H EUDAMEDGSBICM4520H EUDAMEDGSBICM4661H EUDAMEDGSBICR4530H EUDAMEDGSBICR4560H EUDAMEDGSBICR5550H EUDAMEDGSBICR4460H EUDAMEDOICDMH GUDID
- Primary DI / UDI-DI
- 08809892344023 EUDAMED08809917150868 EUDAMED08809892343460 EUDAMED08809892344047 EUDAMED08809892343767 EUDAMED08809917150882 EUDAMED08809892343361 EUDAMED08809892343668 EUDAMED08809892343996 EUDAMED08809892343798 EUDAMED08809892343415 EUDAMED08809892343408 EUDAMED08809892343392 EUDAMED08809892344016 EUDAMED08809917150806 EUDAMED08809892343439 EUDAMED08809892343811 EUDAMED08809892343378 EUDAMED08809892343477 EUDAMED08809892343804 EUDAMED08809892343385 EUDAMED08809892343675 EUDAMED08809917150813 EUDAMED08809917150844 EUDAMED08809892344030 EUDAMED08809917150790 EUDAMED08800209362266 GUDID
- Basic UDI-DI
- 88000406CLASSIBUSANHY
- FDA Product Code
- NDP
- EMDN Code
- Q010599 Dental instruments, single-use - other
- GMDN Term
- Surgical screwdriver, reusable
- Device Class
- Class I
- Regulation Number
- 872.3980
- EU market of registration
- Czechia
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | GSBICR5540H GSBICR4630H GSBICM4560H GSBICR5560H GSBICR4461H GSBICR4650H GSBICM4460H GSBICM4660H GSBICR5460H GSBICR4541H GSBICM4531H GSBICM4530H GSBICM4521H GSBICR5530H GSBICR4520H GSBICM4541H GSBICR4561H GSBICM4461H GSBICM4561H GSBICR4551H GSBICM4520H GSBICM4661H GSBICR4530H GSBICR4560H GSBICR5550H GSBICR4460H | OICDMH |
| Primary DI / UDI-DI | 08809892344023 08809917150868 08809892343460 08809892344047 08809892343767 08809917150882 08809892343361 08809892343668 08809892343996 08809892343798 08809892343415 08809892343408 08809892343392 08809892344016 08809917150806 08809892343439 08809892343811 08809892343378 08809892343477 08809892343804 08809892343385 08809892343675 08809917150813 08809917150844 08809892344030 08809917150790 | 08800209362266 |
| Sterile | No Yes | No |
Other devices from OSSTEM IMPLANT Co., Ltd.
Properties
Other properties (18)
- 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
- Expiration Date: No