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Gum KIT57

by Sunstar Americas, Inc.

Gum KIT57 is a Class I device made by Sunstar Americas, Inc., listed in FDA GUDID since 4 Oct 2024 (UDI-DI 00070942007504), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00070942007504 UDI-DI Date4 Oct 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  • Withdrawn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
Gum
Generic name
Basic manual toothbrush
Model / reference
KIT57
Description
135RA1 Multi-Clean Toothbrush 828PQ Twisted Mint® Floss Picks sample pack 649PA Soft-Picks® Advanced Tight sample pack
Primary DI / UDI-DI
00070942007504
FDA product code
JES, EFW, JET
GMDN term
Basic manual toothbrush
Device class
Class I
Regulation number
872.6390, 872.6855, 872.6650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental flossBasic manual toothbrushPeriodontal pick/brush, reusable

Similar devices

Other devices filed under FDA product code JES (Floss, Dental).

Other devices from Sunstar Americas, Inc.

See all devices from Sunstar Americas, Inc. →

Properties

  • Over-the-counter
  • Convenience kit
  • Premarket exempt
Other properties (12, all answered No)