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Gum®

FDA UDI

Class I (US FDA UDI)

by Sunstar Americas, Inc.

Identity

Trade Name
GUM® FDA UDI
Generic Name
Dental examination kit FDA UDI
Device Name
ORAL CARE CLEANING KIT FDA UDI
Model / Reference
832 FDA UDI
Description
ORAL CARE CLEANING KIT FDA UDI

Identifiers

Catalog Number
RQ FDA UDI
Primary DI / UDI-DI
00070942302722 FDA UDI
FDA Product Code
EAX FDA UDI
EMN FDA UDI
EKB FDA UDI
GMDN Term
Dental examination kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental examination kit

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

Similar devices

Also classified as Dental examination kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sunstar Americas, Inc.

Sources (1)

  • FDA UDI 5a52437a-d0d5-4995-84a4-06ef0d26511e 35 fields · synced Jun 8, 2026