Keystone Industries - Gibbstown

FDA Device Registration & Listing · Gibbstown, NJ, US · Registration 3010002722

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
3010002722
FEI Number
3010002722
Entity Name
Keystone Industries - Gibbstown
City/State/Country
Gibbstown, NJ, US
Establishment Address
480 S Democrat Rd, Gibbstown, NJ 08027, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),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
N
Expiration Date (Year)
2026
510(k) Number
K112597
PMA Number
N/A

All Registered Proprietary Names

Enamelite Ceramic Spray Glaze Diamond D Denture Material KeySplint Soft Copaliner Dentusil Bosworth Pit & Fissure Sealant with Fluoride Trim II Trim Keymill Cora-Caine KeyGuide 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 KeyDenture Base Bosworth Prophy Powder KeyPrint® KeyOrtho IBT™ Versacryl sealant Millennium Sledgehammer Original Truliner Duz-All TruRepair Ultra Fast Softone Trusoft New Truliner Seity Etchant Gel Bosworth Acid Etch

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EIH Powder, Porcelain Dental Class 2 872.6660 2014-10-29
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2007-11-28
MQC Mouthguard, Prescription Unknown Class U N/A 2019-11-15
KMY Positioner, Tooth, Preformed Dental Class 1 872.5525 2019-11-15
EIH Powder, Porcelain Dental Class 2 872.6660 2025-09-16
LBH Varnish, Cavity Dental Class 2 872.3260 2015-12-14
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2015-12-10
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2015-12-14
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2016-01-21
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2018-04-30
KOP Adhesive, Denture, Karaya Dental Class 1 872.3450 2015-12-14
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2018-10-26
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 2016-01-21
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2024-11-14
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2010-12-01
QJJ Indirect Bonding Tray Dental Class 1 872.5410 2020-08-28
EEA Plate, Base, Shellac Dental Class 1 872.6200 2008-11-12
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
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2012-01-09

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
2280629 Keystone Industries CHERRY HILL, NJ, US
2523320 Keystone Industries Myerstown, PA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K143656 H.C. Starck Ceramics GmbH StarCeram® Z-Nature, StarCeram® Z-Smile 2015-07-09
K800400 Dentsply Intl. MAXUM DENTURE RESIN 1980-03-12
K033020 Cmp Industries, LLC IMPAK ACRYLIC REPAIR RESIN LIQUID 2003-12-19
K033295 Novamin Technology, Inc. BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN 2003-10-28
K121698 Dentsply International, Inc. NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN 2012-08-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0017-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010002722. Last updated year: 2026. Please use registration number 3010002722 when referencing this establishment in official correspondence.
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