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Safe Dent PC4016Y

by BGSS Company Inc.

Safe Dent PC4016Y is a Class I device made by BGSS Company Inc., listed in FDA GUDID since 1 May 2024 (UDI-DI 00854014003492), registry data as of 8 Nov 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00854014003492 UDI-DI Date1 May 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  • Withdrawn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
Safe Dent
Generic name
Medicine cup, single-use
Model / reference
PC4016Y
Primary DI / UDI-DI
00854014003492
FDA product code
KYX
GMDN term
Medicine cup, single-use
Device class
Class I
Regulation number
880.6430
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medicine cup, single-use

Similar devices

Other devices filed under FDA product code KYX (Dispenser, Liquid Medication).

Other devices from BGSS Company Inc.

See all devices from BGSS Company Inc. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)