Identity
- Trade Name
- MARK3 FDA UDI
- Generic Name
- Dental prosthesis restorative material, unfilled resin FDA UDI
- Device Name
- Temporary 10:1 Crown & Bridge A1 75gm. Cartridge & 10 Tips FDA UDI
- Model / Reference
- 4101 FDA UDI
- Description
- Temporary 10:1 Crown & Bridge A1 75gm. Cartridge & 10 Tips FDA UDI
Identifiers
- Primary DI / UDI-DI
- D79641010 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Dental prosthesis restorative material, unfilled resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental prosthesis restorative material, unfilled resin
Mark3 by Cargus International, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis restorative material, unfilled resin.
- JET DENTURE REPAIR POWDER — Lang Dental Manufacturing Company, Inc. · Class II
- BIOCRYL XR 1# KIT — Great Lakes Dental Technologies · Class II
- JET XR POWDER — Lang Dental Manufacturing Company, Inc. · Class II
- ORTHO-JET CRYSTAL — Lang Dental Manufacturing Company, Inc. · Class II
- ORTHO-JET TINTING CONCENTRATE LIQUID — Lang Dental Manufacturing Company, Inc. · Class II
- FLUORESCENT ORTHO-JET POWDER — Lang Dental Manufacturing Company, Inc. · Class II
- CONTEMPORARY ORTHO-JET LIQUID — Lang Dental Manufacturing Company, Inc. · Class II
- 2OZ NEON PINK POWDER — Great Lakes Dental Technologies · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cargus International, Inc
Sources (1)
- FDA UDI 9f691a8a-8099-4fe9-b32c-55ae5a5ded2a 34 fields · synced Jun 8, 2026