← Back to catalogue
Direct Abutment Non-Engaging Gold/Plastic 6.0 HL/RPL
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 6106
Identity
- Trade Name
- Direct Abutment Non-Engaging Gold/Plastic 6.0 HL/RPL EUDAMEDNobel Biocare® FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Standardized prosthetic abutments EUDAMEDDirect Abutment Non-Engaging Gold/Plastic 6.0 HL/RPL FDA UDI
- Model / Reference
- 6106 EUDAMEDFDA UDI
- Description
- Direct Abutment Non-Engaging Gold/Plastic 6.0 HL/RPL FDA UDI
Identifiers
- Catalog Number
- 6106 FDA UDI
- Primary DI / UDI-DI
- 07332747207873 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000001697K EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 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
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
No
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
MR Conditional FDA UDI
Direct Abutment Non-Engaging Gold/Plastic 6.0 HL/RPL by Nobel Biocare AB — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 73327470000001697K | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED 90ab571a-2366-4c94-ac3e-d6faf5942252 61 fields · synced Jul 9, 2026
- FDA UDI 4c6047c7-18ca-4a79-a832-2dd2acee95ca 36 fields · synced May 30, 2026