Identity
- Trade Name
- MARK3 FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- Disposable Impression Trays #2 Lower Large 12/pk. - MARK3®* FDA UDI
- Model / Reference
- 1002 FDA UDI
- Description
- Disposable Impression Trays #2 Lower Large 12/pk. - MARK3®* FDA UDI
Identifiers
- Catalog Number
- 1002 FDA UDI
- Primary DI / UDI-DI
- D79610021 FDA UDI
- FDA Product Code
- EHY FDA UDI
- GMDN Term
- Dental impression tray, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental impression tray, single-use
Mark3 by Cargus International, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cargus International, Inc
Sources (1)
- FDA UDI c29d89b7-781c-4d0f-ae8d-589a1c3b8418 35 fields · synced May 31, 2026