Zap Dual Arch Flouride Gel Trays
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Zap Dual Arch Flouride Gel Trays EUDAMEDZap™ Dual Arch Fluoride Gel Trays FDA UDI
- Generic Name
- Fluoride gel tray FDA UDI
- Device Name
- Zap™ Dual Arch Fluoride Gel Trays, Hinged, Small FDA UDI
- Model / Reference
- Flouride Gel Tray EUDAMEDYFTHS EUDAMEDFDA UDI
- Description
- Zap™ Dual Arch Fluoride Gel Trays, Hinged, Small FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10732224001330 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224FluoridetraySP EUDAMED
- Unit of Use DI
- 00732224001333 EUDAMED
- FDA Product Code
- KMT FDA UDI
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-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
- Germany 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
No
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
No
Manufacturing Date
No
Category: Dental impression tray, single-use
Zap Dual Arch Flouride Gel Trays by Crosstex International, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0732224FluoridetraySP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Crosstex International Inc
- EUDAMED SRN
- US-MF-000009642
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 1587936e-7250-4dd0-975b-aeca04d7ac76 61 fields · synced Jul 12, 2026
- FDA UDI 8c454401-10c4-4d93-8077-d6b0fad22e61 34 fields · synced May 30, 2026