PRESIDENT The Original
FDA UDIEUDAMEDClass II (US FDA UDI)
by Dent4You AG
Identity
- Trade Name
- PRESIDENT The Original light body 2 x 53ml EUDAMEDPRESIDENT The Original FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- PRESIDENT TO LB 2 x 53ml FDA UDI
- Model / Reference
- 60019949 EUDAMEDFDA UDIImpression Material EUDAMED
- Description
- PRESIDENT TO LB 2 x 53ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630243635597 EUDAMEDFDA UDI
- Basic UDI-DI
- 76303929ASIL190613K EUDAMED
- FDA Product Code
- ELW FDA UDI
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES EUDAMED
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Silicone dental impression material
PRESIDENT The Original by Dent4You AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dent4You AG
Sources (2)
- FDA UDI d414c19e-1bae-4ef9-8b70-a53f1017ce97 33 fields · synced Jul 9, 2026
- EUDAMED 431b0943-8e4d-4a24-b56d-8343b2a1da80 61 fields · synced Jul 9, 2026