Identity
- Trade Name
- TRAY MIXING W/TAPE 40 SYS-1/ENDUR EUDAMEDOrmco FDA UDI
- Generic Name
- Dental material mixing surface, chairside, single-use FDA UDI
- Device Name
- TRAY MIXING W/TAPE 40 SYS-1/ENDUR EUDAMEDFDA UDI
- Model / Reference
- 740-0076 EUDAMEDFDA UDI
- Description
- TRAY MIXING W/TAPE 40 SYS-1/ENDUR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989061505 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889989-Adh_MixingTray-42 EUDAMED
- Direct Marketing DI
- 00889989061505 EUDAMED
- FDA Product Code
- KXR FDA UDI
- EMDN Code
- Q01010104 DENTAL BONDING AGENTS EUDAMED
- GMDN Term
- Dental material mixing surface, chairside, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3140 FDA UDI
- Market of Registration
- Italy 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
Category: Dentine bonding agent/set
Tray Mixing W/Tape 40 Sys-1/Endur by Ormco Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Dentine bonding agent/set.
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- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
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 | 0889989-Adh_MixingTray-42 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ormco Corporation
- EUDAMED SRN
- US-MF-000038085
- Authorised Representative
- KERR ITALIA SRL IT-AR-000007600
Sources (2)
- EUDAMED 44a225c7-bf29-466a-809d-ef6b32bc0b26 61 fields · synced Jul 14, 2026
- FDA UDI 758d4c11-b227-4edf-a4b0-b6e437e748d8 34 fields · synced May 30, 2026