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8-Hole Bur Block Cover 1” High-Standard (Accessory)

FDA UDI

Class I (US FDA UDI)

by Zirc Dental Products, Inc.

Identity

Trade Name
8-Hole Bur Block Cover 1” High-Standard (Accessory) FDA UDI
Generic Name
Instrument tray cover, reusable FDA UDI
Device Name
Declassified by June 30, 2025 "Maintain cleanliness of burs while being stored Covers FG and RA bur styles Dimensions: 1-5/8"" x 1-5/8"" x 1-1/16"" Surface Disinfect Only" FDA UDI
Model / Reference
50Z401 FDA UDI
Description
Declassified by June 30, 2025 "Maintain cleanliness of burs while being stored Covers FG and RA bur styles Dimensions: 1-5/8"" x 1-5/8"" x 1-1/16"" Surface Disinfect Only" FDA UDI

Identifiers

Primary DI / UDI-DI
00840161302342 FDA UDI
FDA Product Code
FSM FDA UDI
GMDN Term
Instrument tray cover, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
Not 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

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 — 41.3 Millimeter FDA UDI
Width — 41.3 Millimeter FDA UDI
Height — 27 Millimeter FDA UDI

8-Hole Bur Block Cover 1” High-Standard (Accessory) by Zirc Dental Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zirc Dental Products, Inc.

Sources (1)

  • FDA UDI a7d09ab6-6e88-4adf-92ae-e941b7e408e2 35 fields · synced Jun 6, 2026