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Surgical Template (RG) Fully Guided 4 implants
EUDAMEDFDA UDIClass I (EU MDR)
Ref 79163
Identity
- Trade Name
- Surgical Template (RG) Fully Guided 4 implants EUDAMEDNobel Biocare® FDA UDI
- Generic Name
- Dental guided surgery reference plate FDA UDI
- Device Name
- Surgical templates EUDAMEDSurgical Template (RG) Fully Guided 4 implants FDA UDI
- Model / Reference
- 79163 EUDAMEDFDA UDI
- Description
- Surgical Template (RG) Fully Guided 4 implants FDA UDI
Identifiers
- Catalog Number
- 79163 FDA UDI
- Primary DI / UDI-DI
- 07332747110852 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000001857H EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental guided surgery reference plate 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
High-level Disinfectant FDA UDI
Surgical Template (RG) Fully Guided 4 implants 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 | 73327470000001857H | 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 7dbf1a93-2866-423b-828e-34ddfa8cc83a 61 fields · synced Jul 10, 2026
- FDA UDI f9f4ab10-d201-4a2c-81f4-6c6a85d25749 35 fields · synced May 30, 2026