PRESIDENT Impression Trays - Upper Arch - Medium - Size 3
EUDAMEDFDA UDIClass I (EU MDR)
by Dent4You AG
Identity
- Trade Name
- PRESIDENT Impression Trays - Upper Arch - Medium - Size 3 EUDAMEDPRESIDENT FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- PRESIDENT Impression Trays EUDAMEDFull Upper Med Tray Bag # 3, 12 pcs FDA UDI
- Model / Reference
- C6903 EUDAMEDFDA UDI
- Description
- Full Upper Med Tray Bag # 3, 12 pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630392911931 EUDAMEDFDA UDI
- Basic UDI-DI
- 76303929TRAYSVR EUDAMED
- FDA Product Code
- EHY FDA UDI
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
- GMDN Term
- Dental impression tray, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6880 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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental impression tray, single-use
PRESIDENT Impression Trays - Upper Arch - Medium - Size 3 by Dent4You AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76303929TRAYSVR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dent4You AG
- EUDAMED SRN
- CH-MF-000028926
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (2)
- EUDAMED 7a388335-4b21-47d4-ba07-4229bcc9d69b 61 fields · synced Jun 17, 2026
- FDA UDI 793656af-5279-4306-8d75-d9c0f1586567 33 fields · synced May 30, 2026