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Insertion tool SDS1.2 long
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SDS1.2_ITscrew-STModel Insertion tools reusable
Identity
- Trade Name
- Insertion tool SDS1.2 long EUDAMEDSDS1.2 FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Insertion tool SDS1.2 FDA UDI
- Model / Reference
- Insertion tools reusable EUDAMEDSDS1.2_ITscrew-ST EUDAMEDFDA UDI
- Description
- Insertion tool SDS1.2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260468254230 EUDAMEDFDA UDI
- Basic UDI-DI
- 426046825TD01PG08C7 EUDAMED
- Direct Marketing DI
- 04260468254230 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
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
Insertion tool SDS1.2 long 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 | 426046825TD01PG08C7 | 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 22a5568d-2487-43b3-8f6f-fb5d91b73326 61 fields · synced Jul 25, 2026
- FDA UDI e000e5f6-ca70-4e22-979e-37be51a3e015 34 fields · synced May 30, 2026