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PMMA Temp Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 032.036Ref 064.4390Ref 048.242
Identity
- Trade Name
- NC, RC, WN, RN, NNC TEMPORARY ABUTMENT, CAD-TEMP, PMMA TEMPORARY ABUTMENT FDA UDIStraumann BLX Temporary Abutment, VITA CAD-Temp, PMMA FDA UDIStraumann PURE Ceramic Implant System FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- PMMA Temp Abutment EUDAMEDWN Temporary abutment D 10mm, H 10mm, VITA CAD-Temp®, PMMA/TAN FDA UDIWB Temporary Abutment, Ø 5.5mm, GH 1.5mmm, VITA CAD-Temp/TAN FDA UDICI RD Temporary Abutment Vita CAD-Temp®, PMMA/TAN, for Straumann® PURE Ceramic Implant FDA UDI
- Model / Reference
- 032.036 EUDAMED064.4390 EUDAMED048.242 EUDAMEDTemporary Abutments FDA UDI
- Description
- WN Temporary abutment D 10mm, H 10mm, VITA CAD-Temp®, PMMA/TAN FDA UDIWB Temporary Abutment, Ø 5.5mm, GH 1.5mmm, VITA CAD-Temp/TAN FDA UDICI RD Temporary Abutment Vita CAD-Temp®, PMMA/TAN, for Straumann® PURE Ceramic Implant FDA UDI
Identifiers
- Catalog Number
- 048.242 FDA UDI064.4390 FDA UDI032.036 FDA UDI
- Primary DI / UDI-DI
- 07630031714497 EUDAMEDFDA UDI07630031723758 EUDAMEDFDA UDI07630031759276 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763003170073QV EUDAMED
- 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 10 Millimeter FDA UDIHeight — 1.5 Millimeter FDA UDIOuter Diameter — 5.5 Millimeter FDA UDI
PMMA Temp Abutment 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 | 0763003170073QV | 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 (6)
- EUDAMED f8387dd4-804c-4efd-a057-154e84720ef2 61 fields · synced Jul 30, 2026
- FDA UDI 3070ef91-4d35-4204-866f-b8f62a91d2dd 38 fields · synced May 29, 2026
- FDA UDI c793443a-a217-41ba-895d-01d9a4daf667 38 fields · synced May 30, 2026
- FDA UDI cad721e0-bf22-4ff1-a27a-da4023945acc 35 fields · synced May 30, 2026
- EUDAMED 2dcf03d5-b23c-4d9a-a29d-b152b12b94ae 61 fields · synced Jul 8, 2026
- EUDAMED ca9a1e8d-9fd1-4c3e-a36f-4e922a5ce197 61 fields · synced Jul 30, 2026