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Plasdent 8404KIT

by Plasdent Corp.

Plasdent 8404KIT is a Class I device made by Plasdent Corp., listed in FDA GUDID since 20 Jan 2022 (UDI-DI D8328404KIT1), 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 NumberD8328404KIT1 UDI-DI Date20 Jan 2022ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Plasdent
Generic name
Dental material application tool, single-use
Model / Ref / Catalog
8404KIT
Primary DI / UDI-DI
D8328404KIT1
FDA product code
NRD
GMDN term
Dental material application tool, single-use
Device class
Class I
Regulation number
872.6640
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental material application tool, single-use

Other devices from Plasdent Corp.

See all devices from Plasdent Corp. →

Properties

  • Single use
  • Convenience kit
  • Premarket exempt
Other properties (12, all answered No)