Bite Trays Quadrant (40 pcs)
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Bite Trays Quadrant (40 pcs) EUDAMEDBite Trays Quadrant (40 pcs) ‐ Unodent EUDAMEDAstek FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- Bite Trays EUDAMEDBite Trays Quadrant (40 pcs) - Unodent FDA UDI
- Model / Reference
- 114142 EUDAMED114142UNODENT EUDAMEDFDA UDI
- Description
- Bite Trays Quadrant (40 pcs) - Unodent FDA UDI
Identifiers
- Catalog Number
- 114142UNODENT FDA UDI
- Primary DI / UDI-DI
- 10840326424329 EUDAMED10840326423346 EUDAMED00840326423349 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
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
Yes
Manufacturing Date
Yes
Category: Dental impression tray, single-use
Bite Trays Quadrant (40 pcs) by Young Innovations, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression tray, single-use.
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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 | 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 (3)
- EUDAMED abc72d90-3072-4f87-ba37-95e33b74a6be 61 fields · synced Aug 1, 2026
- EUDAMED 00f1ade5-2b67-4e7a-80fd-36bb47638c89 61 fields · synced May 19, 2026
- FDA UDI ba09c29c-5ac8-4989-891b-a56c511e048a 35 fields · synced May 30, 2026