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IS Hex Pick-up Impression Coping Screw
EUDAMEDFDA UDIClass I (EU MDR)
Ref ISPISS20Ref ISIPSL611PRef ISIPNL511PRef ISIPH411PRef ISIPNL711PRef ISIPNL450PRef ISIPH611PRef ISIPH711Ref ISIPHL400PRef ISIPSL511PRef ISIPN400PRef ISIPNL611PRef ISIPHL411PRef ISIPHL450PRef ISPIS20LRef ISIPSL450PRef ISIPHL711Ref ISIPNL411PRef ISIPS711PRef ISIPSL400PRef ISIPN711P
Identity
- Trade Name
- IS Hex Pick-up Impression Coping Screw EUDAMEDIS Hex Pick-up Impression Coping EUDAMEDNeobiotech Implant System FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Dental Surgical Instrument EUDAMEDM2.0, L:17, Long FDA UDI
- Model / Reference
- ISPISS20 EUDAMEDISIPSL611P EUDAMEDISIPNL511P EUDAMEDISIPH411P EUDAMEDISIPNL711P EUDAMEDISIPNL450P EUDAMEDISIPH611P EUDAMEDISIPH711 EUDAMEDISIPHL400P EUDAMEDISIPSL511P EUDAMEDISIPN400P EUDAMEDISIPNL611P EUDAMEDISIPHL411P EUDAMEDISIPHL450P EUDAMEDISPIS20L EUDAMEDFDA UDIISIPSL450P EUDAMEDISIPHL711 EUDAMEDISIPNL411P EUDAMEDISIPS711P EUDAMEDISIPSL400P EUDAMEDISIPN711P EUDAMED
- Description
- M2.0, L:17, Long FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800263100910 EUDAMED08809876909194 EUDAMED08809876909088 EUDAMED08809876908920 EUDAMED08800263100781 EUDAMED08809876909064 EUDAMED08809876908944 EUDAMED08809876905158 EUDAMED08809876908951 EUDAMED08809876909187 EUDAMED08809876909002 EUDAMED08809876909095 EUDAMED08809876908975 EUDAMED08809876908968 EUDAMED08809407156806 EUDAMEDFDA UDI08809876909163 EUDAMED08809876905165 EUDAMED08809876909071 EUDAMED08800263100842 EUDAMED08809876909156 EUDAMED08800263100729 EUDAMED
- Basic UDI-DI
- 880927676NBRSIRSCL1S03FT EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
IS Hex Pick-up Impression Coping Screw by Neobiotech Co., Ltd. — Class I — 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 | 880927676NBRSIRSCL1S03FT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neobiotech Co., Ltd.
- EUDAMED SRN
- KR-MF-000016946
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (22)
- EUDAMED 9165e03b-2f68-4dda-a4e7-b89ba8ff4e32 61 fields · synced Sep 18, 2026
- EUDAMED 95f7129d-d1ab-45f0-b1ec-33b1145bac5e 61 fields · synced May 17, 2026
- EUDAMED a4efc1c9-a4c3-4779-a9a7-0dabcde2be93 61 fields · synced May 17, 2026
- EUDAMED c9db8ca0-aca2-46c5-ae86-23811c2ea45f 61 fields · synced May 17, 2026
- EUDAMED 2fdd4e97-e915-4b32-a73b-f326bd9242cb 61 fields · synced May 17, 2026
- EUDAMED 3eb0965b-5b8c-4551-beba-179de68a8156 61 fields · synced May 17, 2026
- EUDAMED a3d21a26-9071-418a-af37-3c2b6d219769 61 fields · synced May 17, 2026
- EUDAMED 4e009f6c-8549-48b2-8dab-ac64e4e0c9fa 61 fields · synced May 17, 2026
- EUDAMED d4e72f45-8e7b-40df-b2de-e4f27ffa6347 61 fields · synced May 18, 2026
- EUDAMED a0986d74-c382-4101-8843-0932c46dfa1d 61 fields · synced May 18, 2026
- EUDAMED f5b4c1de-e72d-4619-8f20-26027f0f2358 61 fields · synced May 18, 2026
- EUDAMED a1eaf39e-416a-4d24-a578-0da54cdbfafe 61 fields · synced May 18, 2026
- EUDAMED 822d2419-dee6-4c72-bdde-4776e3f1b1ad 61 fields · synced May 18, 2026
- EUDAMED 84d027c6-4e51-4d69-8ada-f9b1beb3fc1e 61 fields · synced May 18, 2026
- EUDAMED e11ed6cb-cba3-46de-9632-b96eb3c6de1e 61 fields · synced May 18, 2026
- EUDAMED 3a7da48e-7da9-4371-9289-97b215bb1652 61 fields · synced May 18, 2026
- EUDAMED 7e0a9c85-dd93-4fe4-b699-5db9fbe31c30 61 fields · synced May 18, 2026
- EUDAMED 23baf838-fc94-4772-b155-c05e5430a7fa 61 fields · synced May 18, 2026
- EUDAMED 112f34e1-b9f6-4945-9910-7478fd8b3800 61 fields · synced May 19, 2026
- EUDAMED 82f758fe-d589-43f7-8683-af5719a9d850 61 fields · synced May 19, 2026
- EUDAMED 2b1d1b8b-460d-4181-9e4a-a20c03277f90 61 fields · synced May 19, 2026
- FDA UDI b393c281-29c6-4272-a719-a7b0749e646c 33 fields · synced May 30, 2026