Gum

FDA UDI

Class I (US FDA UDI)

by Sunstar Americas, Inc.

Identity

Trade Name: GUM FDA UDI
Generic Name: Basic manual toothbrush FDA UDI
Device Name: 135RA1 Multi-Clean Toothbrush 828PQ Twisted Mint® Floss Picks sample pack 649PA Soft-Picks® Advanced Tight sample pack FDA UDI
Model / Reference: KIT58 FDA UDI
Description: 135RA1 Multi-Clean Toothbrush 828PQ Twisted Mint® Floss Picks sample pack 649PA Soft-Picks® Advanced Tight sample pack FDA UDI

Identifiers

Primary DI / UDI-DI: 00070942007511 FDA UDI
FDA Product Code: JES FDA UDI
EFW FDA UDI
JET FDA UDI
GMDN Term: Basic manual toothbrush FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6390 FDA UDI
872.6855 FDA UDI
872.6650 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental floss Basic manual toothbrush Periodontal pick/brush, reusable

Gum by Sunstar Americas, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Sunstar Americas, Inc.

Sources (1)

FDA UDI 919d0da0-d34e-43c4-9936-45f3fa85b89d 33 fields · synced Jun 8, 2026