Skip to content

PDT, Inc. R937 PDT Total Restorative Kit

by PDT, Inc.

PDT, Inc. R937 PDT Total Restorative Kit is an instrument tray (FDA Class I) made by PDT, Inc., listed in FDA GUDID since 27 Jun 2024 (UDI-DI 00813677024978), 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 Number00813677024978 UDI-DI Date27 Jun 2024ListedStatusListed 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  • Withdrawn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
Instrument tray, reusable
Model / Ref / Catalog
R937 PDT Total Restorative Kit, R937
Primary DI / UDI-DI
00813677024978
FDA product code
EAX, FSM, EMN, EJY, EKB, EIX, EKI, EJB, EKH, EKJ, EIY, EIC, EKG, DZN, EGN, EKC
GMDN term
Instrument tray, reusable
Device class
Class I
Regulation number
872.4565, 878.4800
GUDID distribution status
In Commercial Distribution

From the manufacturer

Manufacturer's product page: The PDT Difference

Similar devices

Other devices filed under FDA product code EAX (Mirror, Mouth).

Other devices from PDT, Inc.

See all devices from PDT, Inc. →

Properties

  • Sterilise before use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)