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SDS2.2 standard implant post + 1.5 mm
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref SDS2.2_AP-S+1.5Model SDS Standard implant posts
Identity
- Trade Name
- SDS2.2 standard implant post + 1.5 mm EUDAMEDSDS2.2 FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- SDS2.2 standard implant post + 1.5 mm FDA UDI
- Model / Reference
- SDS Standard implant posts EUDAMEDSDS2.2_AP-S+1.5 EUDAMEDFDA UDI
- Description
- SDS2.2 standard implant post + 1.5 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260468255794 EUDAMEDFDA UDI
- Basic UDI-DI
- 426046825TD01PG03BV 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 IIb 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
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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 implant post + 1.5 mm by SDS Swiss Dental Solutions AG — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190406 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 426046825TD01PG03BV | Class IIb | Active |
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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 (3)
- EUDAMED c0136555-d613-407d-8c5b-37ec27f628bf 61 fields · synced Oct 6, 2026
- FDA UDI 99014802-6436-4c9b-a94f-61b9d3ef7bb1 34 fields · synced May 30, 2026
- FDA 510(k) K190406 1 fields · synced May 18, 2026