Identity
- Trade Name
- Disposable Foam Fluoride Tray (Large) EUDAMEDDisposable Fluoride Trays Large FDA UDI
- Generic Name
- Fluoride gel tray FDA UDI
- Device Name
- Miscellaneous Class I Dental Accessories EUDAMEDDisposable fluoride trays for administering fluoride gel treatment, large, 100 FDA UDI
- Model / Reference
- 23710 EUDAMEDFDA UDI
- Description
- Disposable fluoride trays for administering fluoride gel treatment, large, 100 FDA UDI
Identifiers
- Catalog Number
- 23710 FDA UDI
- Primary DI / UDI-DI
- 00310866001463 EUDAMEDFDA UDI
- Basic UDI-DI
- 03108666001GS EUDAMED
- FDA Product Code
- KMT FDA UDI
- EMDN Code
- Q019003 DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE) EUDAMED
- GMDN Term
- Fluoride gel tray FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6870 FDA UDI
- Market of Registration
- Latvia 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Disposable Foam Fluoride Tray (Large) by Pascal Company, 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 | 03108666001GS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pascal Company Inc.
- EUDAMED SRN
- US-MF-000032036
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 9ccfa053-c5ab-440c-93a2-2d7da4f20b2b 61 fields · synced Jul 29, 2026
- FDA UDI 2f58c5b4-5e51-4dd8-b80d-92b32e925746 35 fields · synced May 30, 2026