Identity
- Trade Name
- MARK3 FDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Device Name
- Blue Streak Diamond Burs Gingival Curettage 878K.018 Coarse Green - MARK3® FDA UDI
- Model / Reference
- 878K-018C FDA UDI
- Description
- Blue Streak Diamond Burs Gingival Curettage 878K.018 Coarse Green - MARK3® FDA UDI
Identifiers
- Catalog Number
- 878K-018C FDA UDI
- Primary DI / UDI-DI
- 00850014374358 FDA UDI
- FDA Product Code
- EJL FDA UDI
- GMDN Term
- Diamond dental bur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3240 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Diamond dental bur, reusable
Mark3 by Cargus International, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Diamond dental bur, reusable.
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- HORICO — Hopf, Ringleb & Co. GmbH & Cie. · 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 7fb64db9-9d52-420c-894c-86abbb06d64c 35 fields · synced Jun 6, 2026