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Mounting Tool Base Guided Pilot Sleeve 1.5/2.0mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 300444
Identity
- Trade Name
- Mounting Tool Base Guided Pilot Sleeve 1.5/2.0mm EUDAMEDNobel Biocare® FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
- Device Name
- Lab tools for surgical templates EUDAMEDMounting Tool Base Guided Pilot Sleeve 1.5/2.0mm FDA UDI
- Model / Reference
- 300444 EUDAMEDFDA UDI
- Description
- Mounting Tool Base Guided Pilot Sleeve 1.5/2.0mm FDA UDI
Identifiers
- Catalog Number
- 300444 FDA UDI
- Primary DI / UDI-DI
- 07332747213508 EUDAMEDFDA UDI
- Basic UDI-DI
- 733274700000020874 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Mounting Tool Base Guided Pilot Sleeve 1.5/2.0mm 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 | 733274700000020874 | 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 a1592098-129b-4d98-85b9-6263d3835b94 61 fields · synced Jun 20, 2026
- FDA UDI 03c1af52-ce68-4e37-87e8-35d7d99a5464 36 fields · synced May 30, 2026