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Bite Impression Coping Driver
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref OICDMRef HICDRRef HICDM
Identity
- Trade Name
- Bite Impression Coping Driver EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Impression Tool System EUDAMED
- Model / Reference
- OICDM EUDAMEDFDA UDIHICDM EUDAMEDFDA UDIHICDR EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800209367995 EUDAMEDFDA UDI08800209374702 EUDAMEDFDA UDI08809892361969 EUDAMEDFDA UDI08800121709194 FDA UDI
- Basic UDI-DI
- 88000406CLASSIBUSANHY EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Czechia 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical screwdriver, reusable
Bite Impression Coping Driver by OSSTEM IMPLANT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical screwdriver, reusable.
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- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Sources (7)
- FDA UDI e5feeea4-be1e-4444-8f1f-ee05d877c384 32 fields · synced Aug 3, 2026
- FDA UDI bdbd25b5-6ca6-4eb6-be28-3285f2e33732 32 fields · synced May 27, 2026
- FDA UDI fb5fac1c-d6b7-4be0-896c-02fb20614cdc 32 fields · synced May 30, 2026
- FDA UDI 677c1f1c-3f2d-4557-9777-8bc9f0d7bd48 32 fields · synced May 30, 2026
- EUDAMED 7da5ff9a-eb52-4a4b-83bb-72355842a307 61 fields · synced Jul 14, 2026
- EUDAMED c238abf6-0c80-4e8b-853e-9e2d945486dc 61 fields · synced Jul 25, 2026
- EUDAMED d8b8bb0e-13d6-4cae-8b92-d904c161345a 61 fields · synced Aug 3, 2026