Identity
- Trade Name
- Magnetic Bur Block 8-Hole Gray EUDAMEDFDA UDIMagnetic Bur Block - 8-Hole - Gray - 1 Count EUDAMED
- Generic Name
- Instrument transport trolley system FDA UDI
- Device Name
- 8-Hole Bur Block Gray EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories EUDAMED
- Model / Reference
- 50Z400I EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161302229 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840161302229 EUDAMED0840161300083F EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument transport trolley system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Dimensions & Sizes
- Size
- Length — 38.1 Millimeter FDA UDIWidth — 38.1 Millimeter FDA UDIHeight — 12.7 Millimeter FDA UDI
Magnetic Bur Block 8-Hole Gray by Zirc Dental Products, Inc. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840161302229 | Class I | Active |
| EUDAMED | European Union | CE/MDR | B-00840161302229 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zirc Dental Products Inc.
- EUDAMED SRN
- US-MF-000021065
- Authorised Representative
- Medicom GmbH DE-AR-000005612
Sources (3)
- EUDAMED 0fc1f1f3-bddb-42d6-8b08-c433ed4ce482 61 fields · synced Jun 19, 2026
- EUDAMED bc3aaa01-c7c2-44c2-8371-15cddd6850b2 61 fields · synced May 17, 2026
- FDA UDI 55bf2045-6b85-4539-9b47-586af1376f77 33 fields · synced May 30, 2026