Identity
- Trade Name
- 14-Hole Bur Block Tall EUDAMED14-Hole Bur Block Cover 2” High-HP Lab Burs (Accessory) FDA UDI
- Generic Name
- Instrument tray cover, reusable FDA UDI
- Device Name
- 14-Hole Bur Block Tall EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories EUDAMEDDeclassified as non-medical device by June 30, 2025 "Maintain cleanliness of burs while being stored Covers lab and surgical bur styles Dimensions: 3-1/8"" x 1-5/8"" x 2-1/4"" Surface Disinfect Only" FDA UDI
- Model / Reference
- 50Z405 EUDAMEDFDA UDI
- Description
- Declassified as non-medical device by June 30, 2025 "Maintain cleanliness of burs while being stored Covers lab and surgical bur styles Dimensions: 3-1/8"" x 1-5/8"" x 2-1/4"" Surface Disinfect Only" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161302526 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840161302526 EUDAMED0840161300083F EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument tray cover, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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 — 79.4 Millimeter FDA UDIWidth — 41.3 Millimeter FDA UDIHeight — 57.2 Millimeter FDA UDI
Category: Instrument tray, reusable
14-Hole Bur Block Tall by Zirc Dental Products, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00840161302526 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161302526 | 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 6de57979-d76b-400d-b69d-2d10f475ba4f 61 fields · synced Jul 29, 2026
- EUDAMED 676cf15a-89fa-4e0b-b576-6fe273b31b44 61 fields · synced May 19, 2026
- FDA UDI 1c4c5133-6018-46a7-a685-f43d7c278726 35 fields · synced May 30, 2026