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PRESIDENT Impression Trays AC - Lower Arch - Medium - Size 4
EUDAMEDFDA UDIClass I (EU MDR)
Ref C6953
by Dent4You AG
Identity
- Trade Name
- PRESIDENT Impression Trays AC - Lower Arch - Medium - Size 4 EUDAMEDPRESIDENT FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- PRESIDENT Impression Trays EUDAMEDFull Lower Med Tray Bag # 4, AC, 12 pcs FDA UDI
- Model / Reference
- C6953 EUDAMEDFDA UDI
- Description
- Full Lower Med Tray Bag # 4, AC, 12 pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630392912044 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
PRESIDENT Impression Trays AC - Lower Arch - Medium - Size 4 by Dent4You AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 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 de179a94-0a75-47fc-a6d9-4e6f4d980bd7 61 fields · synced Jun 18, 2026
- FDA UDI 5d00b39b-ea34-4fb0-876f-8e46567cc5d5 33 fields · synced May 30, 2026