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Protective Cap (injection moulded)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 024.2312-04
Identity
- Trade Name
- CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Protective Cap (injection moulded) EUDAMEDNC Protective Cap, for Cementable Abutment, D 3.5mm, AH 4mm, PEEK FDA UDI
- Model / Reference
- 024.2312-04 EUDAMEDProtective caps FDA UDI
- Description
- NC Protective Cap, for Cementable Abutment, D 3.5mm, AH 4mm, PEEK FDA UDI
Identifiers
- Catalog Number
- 024.2312-04 FDA UDI
- Primary DI / UDI-DI
- 07630031710307 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763003170083QY EUDAMED
- Unit of Use DI
- 07630031755889 EUDAMED
- 510(k) Number
- K080286 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 IIa 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
No
EUDAMEDFDA UDI
Reusable
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.5 Millimeter FDA UDI
Protective Cap (injection moulded) by Institut Straumann 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 | 0763003170083QY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 161ffdef-7207-4566-bbf6-330b0acedfdd 61 fields · synced Jun 18, 2026
- FDA UDI 21e3e374-15a4-4785-845c-9f1fb937cb88 38 fields · synced May 30, 2026