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ProFlare

FDA UDI

Class I (US FDA UDI)

by Premier Dental Products Company

Identity

Trade Name
ProFlare FDA UDI
Generic Name
Dental polishing cup, single-use FDA UDI
Device Name
ProFlare Articulating DPA (Bag of 125) FDA UDI
Model / Reference
5500150 FDA UDI
Description
ProFlare Articulating DPA (Bag of 125) FDA UDI

Identifiers

Primary DI / UDI-DI
00348783001181 FDA UDI
FDA Product Code
EHK FDA UDI
GMDN Term
Dental polishing cup, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6290 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

Category: Dental polishing cup, single-use

ProFlare by Premier Dental Products Company — 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

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Manufacturer

Manufacturer
Premier Dental Products Company

Sources (1)

  • FDA UDI d71fc6f3-be72-4845-8692-87b3ebfda180 33 fields · synced Jun 1, 2026