Identity
- Trade Name
- Orthodontic Tray Size 2 Lower Orange EUDAMEDAstek FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- Bite Trays EUDAMEDOrthodontic Trays Size 2 Lower Orange (50 pcs) FDA UDI
- Model / Reference
- 117143 EUDAMEDFDA UDI
- Description
- Orthodontic Trays Size 2 Lower Orange (50 pcs) FDA UDI
Identifiers
- Catalog Number
- 117143 FDA UDI
- Primary DI / UDI-DI
- 10840326423216 EUDAMED00840326423219 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
Orthodontic Tray Size 2 Lower Orange by Young Innovations, Inc. — 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 | 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 49c402e7-1ecb-4dbd-92e8-dd9655dc14c6 61 fields · synced Jun 19, 2026
- FDA UDI 4dcfd29a-3f58-4d10-8a7a-381ac9638cff 35 fields · synced May 30, 2026