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Parkell®

FDA UDI

Class I (US FDA UDI)

by Parkell, Inc.

Identity

Trade Name
Parkell® FDA UDI
Generic Name
Diamond dental bur, single-use FDA UDI
Device Name
379-023F Sterile FG Diamond Burs, Football, Fine Grit FDA UDI
Model / Reference
SDS-379-023F FDA UDI
Description
379-023F Sterile FG Diamond Burs, Football, Fine Grit FDA UDI

Identifiers

Catalog Number
SDS-379-023F FDA UDI
Primary DI / UDI-DI
10810000527677 FDA UDI
FDA Product Code
DZP FDA UDI
GMDN Term
Diamond dental bur, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4535 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 3.9 Millimeter FDA UDI
Outer Diameter — 2.3 Millimeter FDA UDI

Category: Diamond dental bur, single-use

Parkell® by Parkell, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diamond dental bur, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Parkell, Inc.

Sources (1)

  • FDA UDI 92e4be88-1123-4bce-928b-0870db6e859e 36 fields · synced May 30, 2026