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ProFlare 5500150

by Premier Dental Products Company

ProFlare 5500150 is a Class I device made by Premier Dental Products Company, listed in FDA GUDID since 26 Oct 2023 (UDI-DI 00348783001181), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00348783001181 UDI-DI Date26 Oct 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
ProFlare
Generic name
Dental polishing cup, single-use
Model / reference
5500150
Primary DI / UDI-DI
00348783001181
FDA product code
EHK
GMDN term
Dental polishing cup, single-use
Device class
Class I
Regulation number
872.6290
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental polishing cup, single-use

Other devices from Premier Dental Products Company

See all devices from Premier Dental Products Company →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)