Identity
- Trade Name
- iphysio® FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Try-in abutment EUDAMEDUniversal Try-in Abutment Size C1 FDA UDI
- Model / Reference
- IE_U.C1 EUDAMEDFDA UDI
- Description
- Universal Try-in Abutment Size C1 FDA UDI
Identifiers
- Catalog Number
- IE_U.C1 FDA UDI
- Primary DI / UDI-DI
- 03700977506365 EUDAMEDFDA UDI
- Basic UDI-DI
- 37009775pilier-essaiQL EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Height — 1 Millimeter FDA UDI
Try-in abutment by Euroteknika — Class I — 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 | 37009775pilier-essaiQL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Euroteknika
- EUDAMED SRN
- FR-MF-000004032
Sources (2)
- EUDAMED 947b09a7-90f7-44b5-a973-4ef8ef00ad86 61 fields · synced Jun 8, 2026
- FDA UDI 2d666c1b-4b89-40f7-bce7-e3e346b46cfe 36 fields · synced May 30, 2026