Identity
- Trade Name
- Straumann TLX Implant System FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Temporary Abutment, non Sterile EUDAMEDRT Temporary Abutment, for bridge, H10.3mm, TAN FDA UDI
- Model / Reference
- 037.1001 EUDAMEDTemporary Abutments FDA UDI
- Description
- RT Temporary Abutment, for bridge, H10.3mm, TAN FDA UDI
Identifiers
- Catalog Number
- 037.1001 FDA UDI
- Primary DI / UDI-DI
- 07630031746528 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763003170102QB EUDAMED
- 510(k) Number
- K200586 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Height — 10.3 Millimeter FDA UDI
Temporary Abutment, non Sterile by Institut Straumann 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 | 0763003170102QB | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Institut Straumann AG
- EUDAMED SRN
- CH-MF-000009933
- Authorised Representative
- Etkon GmbH DE-AR-000009335
Sources (2)
- EUDAMED 63f9a1c8-fcd2-44df-83e0-871499314a73 61 fields · synced Jun 18, 2026
- FDA UDI 2e7efcaa-aae5-4e43-9f26-81a5d475f168 37 fields · synced May 30, 2026