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SDS2.2 15° standard implant post
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref SDS2.2_AP-S15°Model SDS Standard implant posts
Identity
- Trade Name
- SDS2.2 15° standard implant post EUDAMEDSDS2.2 FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- SDS2.2 15° standard implant post FDA UDI
- Model / Reference
- SDS Standard implant posts EUDAMEDSDS2.2_AP-S15° EUDAMEDFDA UDI
- Description
- SDS2.2 15° standard implant post FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260468255787 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 15° standard implant post by SDS Swiss Dental Solutions AG — Class IIb — 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 | 426046825TD01PG03BV | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 51e377bc-4f2a-48b7-a024-315b50134510 61 fields · synced Jun 19, 2026
- FDA UDI 7143c450-03c1-49ae-92f3-169fed5189e9 34 fields · synced May 30, 2026