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Impression Tray Upper Left / Lower Right (25) #8 Unodent
EUDAMEDFDA UDIClass I (EU MDR)
Ref 116132UNODENT
Identity
- Trade Name
- Impression Tray Upper Left / Lower Right (25) #8 Unodent EUDAMEDAstek FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- Bite Trays EUDAMEDImpression Tray Upper Left / Lower Right (25) #8 Unodent FDA UDI
- Model / Reference
- 116132UNODENT EUDAMEDFDA UDI
- Description
- Impression Tray Upper Left / Lower Right (25) #8 Unodent FDA UDI
Identifiers
- Catalog Number
- 116132UNODENT FDA UDI
- Primary DI / UDI-DI
- 10840326423445 EUDAMED00840326423448 FDA UDI
- Basic UDI-DI
- 0843471116350D36733EHYDX 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
- Ireland 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental impression tray, single-use
Impression Tray Upper Left / Lower Right (25) #8 Unodent by Young Innovations, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Dental impression tray, single-use.
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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 | 0843471116350D36733EHYDX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Young Innovations Inc
- EUDAMED SRN
- US-MF-000017796
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 0f48ab24-295a-473b-876a-1498fa1fa118 61 fields · synced Jun 19, 2026
- FDA UDI d045e2be-95ba-4af5-80a7-9a0f4ddad8e4 35 fields · synced May 30, 2026