Polishing Protector Ø4.1
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- POLISH PROTECTOR Ø4.1MM ROT. EUDAMEDPOLISHING PROTECTOR Ø4.1 FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- POLISHING PROTECTOR EUDAMEDPOLISHING PROTECTOR Ø4.1 FDA UDI
- Model / Reference
- PPI 4100 EUDAMEDFDA UDIPROSTHETIC COMPONENT - NON-STERILE LABORATORY DEVICE EUDAMED
- Description
- POLISHING PROTECTOR Ø4.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07899995212115 EUDAMEDFDA UDI
- Basic UDI-DI
- 999520000047K8 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P010299 ODONTOLOGICAL PROSTHESES - OTHER 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
No
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
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dental implant suprastructure, temporary, preformed, single-use
Polishing Protector Ø4.1 by S.I.N. - Sistema DE Implante Nacional S.A. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- S.I.N. - Sistema DE Implante Nacional S.A.
Sources (2)
- FDA UDI 5b9a8d51-a2ca-4bec-a4a7-c9e7d9f7bddd 33 fields · synced Jun 20, 2026
- EUDAMED e1c941f1-48b4-4e8c-9a9c-77348b708ba3 61 fields · synced Jun 20, 2026