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: MICROTIP SOFT/REGULAR, PROXABRUSH GO-BETWEENS FDA UDI
Model / Reference: 470 FDA UDI
Description: MICROTIP SOFT/REGULAR, PROXABRUSH GO-BETWEENS FDA UDI

Identifiers

Catalog Number: RQB FDA UDI
Primary DI / UDI-DI: 00070942127448 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

Yes

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 — 69.95 Millimeter FDA UDI
Width — 7.11 Millimeter FDA UDI
Depth — 7.11 Millimeter FDA UDI
Height — 190 Millimeter FDA UDI
Width — 13.38 Millimeter FDA UDI
Depth — 12.294 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

Similar devices

Also classified as Periodontal pick/brush, reusable.

Opalpix — ULTRADENT PRODUCTS, INC. · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
Equate — Walmart Stores · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class I
PILLING — TELEFLEX INCORPORATED · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Sunstar Americas, Inc.

Sources (1)

FDA UDI e72c679a-88a5-4f29-91f2-811b46d960e7 36 fields · synced Jun 8, 2026