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PDT, Inc. R927 PDT Tissue Grafting Kit

by PDT, Inc.

PDT, Inc. R927 PDT Tissue Grafting Kit is a manual non-rotary dental instrument handle (FDA Class I) made by PDT, Inc., listed in FDA GUDID since 26 Jun 2024 (UDI-DI 00813677024916), 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 Number00813677024916 UDI-DI Date26 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  • Withdrawn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
Manual non-rotary dental instrument handle
Model / Ref / Catalog
R927 PDT Tissue Grafting Kit, R927
Primary DI / UDI-DI
00813677024916
FDA product code
EAX, FSM, EMS, EKB, EIX, EJB, EMJ, EMO, GDZ, EJY, EGN, HXK
GMDN term
Manual non-rotary dental instrument handle
Device class
Class I
Regulation number
872.4565, 878.4800, 888.4540
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)