Keystone Industries - Delran

FDA Device Registration & Listing · Delran, NJ, US · Registration 2518690

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2518690
FEI Number
2518690
Entity Name
Keystone Industries - Delran
City/State/Country
Delran, NJ, US
Establishment Address
2702 Cindel Drive, Unit #2, Cindel Business Park, Delran, NJ 08075, US
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Keystone Industries (Owner Number: 9007845)
Owner / Operator Contact Address
480 S. Democrat Road, --, Gibbstown, NJ 08027, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Optimize General Purpose Ultrasonic Cleaner-Liquid Optimize Tartar, Stain & Permanent Cement Remover Ultrasonic Powder Optimize General Purpose Ultrasonic Cleaner-Powder Optimize Tartar, Stain & permanent Cement Remover Ultrasonic Liquid Optimize Refresh Enzymatic Ultrasonic Instrument Cleaner

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 2016-01-21

Official Correspondent

Gloria Zuclich

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Keystone Industries
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2280629 Keystone Industries CHERRY HILL, NJ, US
2523320 Keystone Industries Myerstown, PA, US
3010002722 Keystone Industries - Gibbstown Gibbstown, NJ, US

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2025 Young Dental Manufacturing I, LLC 1
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2518690. Last updated year: 2026. Please use registration number 2518690 when referencing this establishment in official correspondence.
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