Pala

FDA UDI

Class I (US FDA UDI)

by Kulzer, Inc.

Identity

Trade Name: Pala FDA UDI
Generic Name: Denture cleanser FDA UDI
Device Name: Pala Brillance Denture Cleanser 64 tab FDA UDI
Model / Reference: 66077539 FDA UDI
Description: Pala Brillance Denture Cleanser 64 tab FDA UDI

Identifiers

Catalog Number: 66077539 FDA UDI
Primary DI / UDI-DI: J014660775391 FDA UDI
FDA Product Code: EFT FDA UDI
GMDN Term: Denture cleanser FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3520 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Denture cleanser

Pala by Kulzer, 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: Kulzer, Inc.

Sources (1)

FDA UDI 745331a9-dc77-4cd2-8c10-848cf3f73468 35 fields · synced Jun 8, 2026