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PDT, Inc. R333 27/29 Burnisher

by PDT, Inc.

PDT, Inc. R333 27/29 Burnisher is a manual dental burnisher (FDA Class I; FDA product code EKJ, Burnisher, Operative) made by PDT, Inc., listed in FDA GUDID since 30 Apr 2021 (UDI-DI 00813677021779), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00813677021779 UDI-DI Date30 Apr 2021ListedStatusListed 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  • Withdrawn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
PDT, Inc.
Generic name
Manual dental burnisher, reusable
Model / Ref / Catalog
R333 27/29 Burnisher, R333
Primary DI / UDI-DI
00813677021779
FDA product code
EKJ
GMDN term
Manual dental burnisher, reusable
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code EKJ (Burnisher, Operative).

Other devices from PDT, Inc.

See all devices from PDT, Inc. →

Properties

  • Sterilise before use
  • Premarket exempt
Other properties (13, all answered No)