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Impress Cop Closed Tray Conical Connection RP Ø5x9mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 36543
Identity
- Trade Name
- Impress Cop Closed Tray Conical Connection RP Ø5x9mm EUDAMEDNobel Biocare® FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
- Device Name
- Transfer to model tools Ir EUDAMEDImpress Cop Closed Tray Conical Connection RP Ø5x9mm FDA UDI
- Model / Reference
- 36543 EUDAMEDFDA UDI
- Description
- Impress Cop Closed Tray Conical Connection RP Ø5x9mm FDA UDI
Identifiers
- Catalog Number
- 36543 FDA UDI
- Primary DI / UDI-DI
- 07332747210873 EUDAMEDFDA UDI
- Basic UDI-DI
- 733274700000013674 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5.000 Millimeter FDA UDIHeight — 9.000 Millimeter FDA UDI
Impress Cop Closed Tray Conical Connection RP Ø5x9mm by Nobel Biocare AB — 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 | 733274700000013674 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED 248103a8-335d-4b36-873d-714bafa7ab58 61 fields · synced Jul 9, 2026
- FDA UDI 9d3a0cf0-4722-4d4e-9556-699c4aef84b4 37 fields · synced May 30, 2026