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Preat

FDA UDI

Class I (US FDA UDI)

by PREAT Corporation

Identity

Trade Name
Preat FDA UDI
Generic Name
Diamond dental bur, single-use FDA UDI
Device Name
M2 Spacer Diamond (2-Pack) FDA UDI
Model / Reference
2RT0H20 FDA UDI
Description
M2 Spacer Diamond (2-Pack) FDA UDI

Identifiers

Catalog Number
2RT0H20 FDA UDI
Primary DI / UDI-DI
00842092173336 FDA UDI
FDA Product Code
EJB FDA UDI
GMDN Term
Diamond dental bur, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Diamond dental bur, single-use

Preat by PREAT Corporation — 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
PREAT Corporation

Sources (1)

  • FDA UDI 837a291b-254e-4139-b80d-5859ec6e74c2 35 fields · synced Jun 1, 2026