Gum®

FDA UDI

Class I (US FDA UDI)

by Sunstar Americas, Inc.

Identity

Trade Name: GUM® FDA UDI
Generic Name: Periodontal pick/brush, reusable FDA UDI
Device Name: PROXABRUSH REFILLS TIGHT FDA UDI
Model / Reference: 414 FDA UDI
Description: PROXABRUSH REFILLS TIGHT FDA UDI

Identifiers

Catalog Number: PQF FDA UDI
Primary DI / UDI-DI: 00070942752763 FDA UDI
FDA Product Code: EFW FDA UDI
GMDN Term: Periodontal pick/brush, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6855 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Height — 6.86 Millimeter FDA UDI
Width — 6.86 Millimeter FDA UDI
Depth — 24.05 Millimeter FDA UDI

Category: 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 af262c4e-7f27-498a-90e7-438d58426825 36 fields · synced Jun 8, 2026