← Back to catalogue

Petite Pearl

FDA UDI

Class I (US FDA UDI)

by Metrex Research

Identity

Trade Name
Petite Pearl FDA UDI
Generic Name
Dental polishing cup, single-use FDA UDI
Device Name
Petite Pearl Disposable Prophy Angle Soft Cup, 500ct Box FDA UDI
Model / Reference
10-9528 FDA UDI
Description
Petite Pearl Disposable Prophy Angle Soft Cup, 500ct Box FDA UDI

Identifiers

Primary DI / UDI-DI
00615375011799 FDA UDI
FDA Product Code
EHL FDA UDI
GMDN Term
Dental polishing cup, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6010 FDA UDI
Commercial Distribution
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

No

FDA UDI

Category: Dental polishing cup, single-use

Petite Pearl by Metrex Research — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental polishing cup, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Metrex Research

Sources (1)

  • FDA UDI 8368ab16-4e86-4aeb-aec9-c8a56d559292 34 fields · synced May 30, 2026