Identity
- Trade Name
- N/A FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw analog, reusable FDA UDI
- Device Name
- Laboratory Components EUDAMEDLuting Screw for Ø3.3 Provata® Passive Abutment FDA UDI
- Model / Reference
- PA-M16-LS EUDAMEDFDA UDI
- Description
- Luting Screw for Ø3.3 Provata® Passive Abutment FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06009544037798 EUDAMEDFDA UDI
- Basic UDI-DI
- 6009544038799L EUDAMED
- Direct Marketing DI
- 06009544037798 EUDAMED
- 510(k) Number
- K222457 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental prosthesis/implant abutment screw analog, reusable 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 aa592b65-3039-40d1-9954-251fe57c03ad 61 fields · synced Jul 29, 2026
- FDA UDI 0cab65f6-e7b3-4afd-8c73-8008137832f6 34 fields · synced May 30, 2026