Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004122135

FEI Number

3004122135

Entity Name

Andpak, Inc.

City/State/Country

Morgan Hill, CA, US

Establishment Address

400 Jarvis Dr., Morgan Hill, CA 95037, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Andpak, Inc (Owner Number: 10056984)

Owner / Operator Contact Address

400 JARVIS DR, Morgan Hill, CA 95037, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2018-02-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Andpak, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004122135. Last updated year: 2026. Please use registration number 3004122135 when referencing this establishment in official correspondence.