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SDS2.2 Standard screw PEEK
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SDS2.2_SS-PModel SDS Standard screws
Identity
- Trade Name
- SDS2.2 Standard screw PEEK EUDAMEDSDS2.2 FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- SDS2.2 standard PEEK screw FDA UDI
- Model / Reference
- SDS Standard screws EUDAMEDSDS2.2_SS-P EUDAMEDFDA UDI
- Description
- SDS2.2 standard PEEK screw FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260468255558 EUDAMEDFDA UDI
- Basic UDI-DI
- 426046825TD01PG06C3 EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
SDS2.2 Standard screw PEEK by SDS Swiss Dental Solutions AG — Class IIa — 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 | 426046825TD01PG06C3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SDS Swiss Dental Solutions AG
- EUDAMED SRN
- CH-MF-000019073
- Authorised Representative
- SDS Deutschland GmbH DE-AR-000005774
Sources (2)
- EUDAMED ec58e01a-c5ef-4212-a188-1245417c5899 61 fields · synced Oct 6, 2026
- FDA UDI 5b5a5775-f31d-4a50-bf8a-df278a39b6a6 34 fields · synced May 30, 2026