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PDT, Inc. R349S Backaction Plugger 11/12 Serrated

by PDT, Inc.

PDT, Inc. R349S Backaction Plugger 11/12 Serrated is a dental amalgam condenser (FDA Class I; FDA product code EKG, Condenser, Amalgam And Foil, Operative) made by PDT, Inc., listed in FDA GUDID since 30 Apr 2021 (UDI-DI 00813677021878), 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 Number00813677021878 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  • Withdrawn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
Dental amalgam condenser, reusable
Model / Ref / Catalog
R349S Backaction Plugger 11/12 Serrated, R349S
Primary DI / UDI-DI
00813677021878
FDA product code
EKG
GMDN term
Dental amalgam condenser, reusable
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental amalgam condenser, reusable

Similar devices

Other devices filed under FDA product code EKG (Condenser, Amalgam And Foil, Operative).

Other devices from PDT, Inc.

See all devices from PDT, Inc. →

Properties

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