Identity
- Trade Name
- MARK3 FDA UDI
- Generic Name
- Dentifrice FDA UDI
- Device Name
- Enamel Care Soft Viscosity Prophy Paste Medium Assorted w/TCP B.Gum, Cherry, Mint & Raspberry 200/bx. - MARK3® FDA UDI
- Model / Reference
- 1540-SU FDA UDI
- Description
- Enamel Care Soft Viscosity Prophy Paste Medium Assorted w/TCP B.Gum, Cherry, Mint & Raspberry 200/bx. - MARK3® FDA UDI
Identifiers
- Catalog Number
- 1540-SU FDA UDI
- Primary DI / UDI-DI
- D7961540SU1 FDA UDI
- FDA Product Code
- EJR FDA UDI
- GMDN Term
- Dentifrice FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6030 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dentifrice
Mark3 by Cargus International, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dentifrice.
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class I
- Topex® Prophy Paste — Dentsply International · Class I
- Omni — Keystone Industries · Class I
- Disposable Prophy Angles, 105° Contra Angle Clear, Ribbed and Webbed — Premium Plus (Dongguan) Limited · Class IIa
- Dental City — ICP, INC. · Class I
- Blasting Powder — Bioclear Matrix Systems, LLC · Class I
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY · Class I
- Prophy Brush — Huanghua Promisee Dental Co.Ltd. · Class I
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 ad527411-f2c1-49fe-98d8-2f6e9a249c9a 36 fields · synced Jun 8, 2026