Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Impression Copings EUDAMEDTransfer Impression Coping, Non-Engaging, IT Ø4.8 Interface, 4mm Cuff FDA UDI
- Model / Reference
- ITS-TRCNE-4 EUDAMEDFDA UDI
- Description
- Transfer Impression Coping, Non-Engaging, IT Ø4.8 Interface, 4mm Cuff FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06009544014294 EUDAMEDFDA UDI
- Basic UDI-DI
- 6009544038789J EUDAMED
- Direct Marketing DI
- 06009544014294 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Impression Copings is a medical device designed to provide secure and reliable implantation solutions for dental and maxillofacial procedures. The device features a unique design, allowing for easy insertion and removal, and is compatible with various implant systems. By prioritizing patient safety and comfort, Impression Copings has established itself as a trusted solution in the industry.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6009544038789J | 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 bd28e754-f59b-4d70-8304-3dace5cf5e2e 61 fields · synced Jul 17, 2026
- FDA UDI 100b5006-2358-45f3-8d16-c0ac0ac4813a 33 fields · synced May 30, 2026