Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2280629

FEI Number

1000121639

Entity Name

Keystone Industries

City/State/Country

CHERRY HILL, NJ, US

Establishment Address

616 Hollywood Ave, CHERRY HILL, NJ 08002, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Keystone Industries (Owner Number: 9007845)

Owner / Operator Contact Address

480 S. Democrat Road, --, Gibbstown, NJ 08027, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K032773

PMA Number

N/A

All Registered Proprietary Names

Versacryl Denture Material KeyPrint KeySplint Hard Trim II Trim KeyPrint® KeyOrtho IBT Proform Blue Tray Proform Pink Baseplate Fastray Custom Tray Material Proform ProSplint Proform Splint KeyTray KeyDenture Try-In Bosworth Zinc Phosphate Cement Mizzy Fleck's Zinc Cement Mizzy Polycarboxylate (PCA) Cement Powder KeyDenture Base Millennium Sledgehammer Original Truliner Duz-All TruRepair Ultra Fast Softone Trusoft New Truliner Diamond D Denture Material

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2011-10-24
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2021-04-14
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2021-04-14
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2021-04-14
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2016-01-21
QJJ	Indirect Bonding Tray	Dental	Class 1	872.5410	2020-08-28
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	1995-12-26
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-11-28
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2024-11-14
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2007-11-28
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2016-01-21
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2007-11-28

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
2518690	Keystone Industries - Delran	Delran, NJ, US
2523320	Keystone Industries	Myerstown, PA, US
3010002722	Keystone Industries - Gibbstown	Gibbstown, NJ, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
2950685	CO-ORAL-ITE DENTAL MFG. CO.	DIAMOND SPRINGS, CA, US
3032727	TALON ACRYLICS, INC.	Winchester, OR, US
3008320092	Shandong Huge Dental Material Corporation	Rizhao Shandong, CN
1410097	GC AMERICA INC.	ALSIP, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2280629. Last updated year: 2026. Please use registration number 2280629 when referencing this establishment in official correspondence.