Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Laboratory Components EUDAMEDPlastic Sleeve for IT Ø4.8 Interface Passive Abutment, Engaging FDA UDI
- Model / Reference
- ITS-PA-P EUDAMEDFDA UDI
- Description
- Plastic Sleeve for IT Ø4.8 Interface Passive Abutment, Engaging FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06009544014102 EUDAMEDFDA UDI
- Basic UDI-DI
- 6009544038799L EUDAMED
- Direct Marketing DI
- 06009544014102 EUDAMED
- 510(k) Number
- K061169 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Portugal 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Laboratory Components by Southern Implants (pty) 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 | 6009544038799L | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Southern Implants (Pty) Ltd
- EUDAMED SRN
- ZA-MF-000035362
- Authorised Representative
- Southern Implants Europe AB SE-AR-000032508
Sources (2)
- EUDAMED 26fb6f1e-19bc-42b5-b582-ce929b4fe0b6 61 fields · synced Jun 18, 2026
- FDA UDI 27f519a4-bc3a-4cbe-a1e2-0b6e5edebd89 34 fields · synced May 30, 2026