Keystone Industries

FDA Device Registration & Listing · Myerstown, PA, US · Registration 2523320

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
2523320
FEI Number
2523320
Entity Name
Keystone Industries
City/State/Country
Myerstown, PA, US
Establishment Address
52 West King St, Myerstown, PA 17067, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Keystone Industries (Owner Number: 9007845)
Owner / Operator Contact Address
480 S. Democrat Road, --, Gibbstown, NJ 08027, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Comfort Cushion Analgesia Mask Prehma Cotton Rolls Enamelite Ceramic Spray Glaze Trim II Trim Clearmet Plastopaste Superpaste Superbite NIU Bleaching Systems Prehma Sleeves Prehma Pro-Guard Towels Prehma Barrier Film Simplastic Patient Drape Simplastic Tray Cover Simplastic Uni-Cover Simplastic Sleeves FP3D Prehma Surgical Blades Prehma Sterile Disposable Scalpels Versacryl sealant Prehma HVE Tips Keystone HVE Tips KeySplint Soft Keystone Industries Clasp Wire Bosworth Prophy Powder Comfort Cushion Analgesia Mask Prehma Articulating Paper Prehma Horseshoe Articulating Paper Mizzy Pressure Indicating Paste (PIP) Mizzy PIP Aerosol Keystone Plasterless Articulator Luxury Articulator Keystone Articulators Deluxe Magnetic Articulator Prehma Prophylaxis Cups Prehma Prophylaxis Polishing Brushes Keystone Industries Prophy Cup Proflex Prehma Disposable Dental Needles Keystone Industries Mesh Strengtheners Keystone Industries Twist Plate Strengtheners Keystone Industries Grid Strengtheners Frego Strengthener Keystone Industries Lingual Bars Keystone Gelato Prophy Paste Seity Etchant Gel Bosworth Acid Etch Prehma Cotton Tipped Applicators Prehma Surgical Molded Masks Prehma Procedure masks Prehma Optima Procedure Mask Consistency Putty Prehma Rubber Dam Prehma Clear & UV Safety Glasses Comfort Cushion Analgesia Mask Bosworth Zinc Phosphate Cement Mizzy Fleck's Zinc Cement Mizzy Polycarboxylate (PCA) Cement Powder Versacryl Denture Material Diamond D Denture Material 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 Prehma Nero Disposable Prophy Angles Keystone Disposable Prophy Angles Fortis Disposable Prophy Angles Prehma Matrix Bands, Rolls & Retainers Wonder Wedges Interproximal Wedges KeyPrint KeySplint Hard Keystone Industries Tongue Scraper Flexo Disposable Saliva Ejectors Prehma Saliva Ejectors Prehma Carbide Burs KeyDenture Base Prehma Disposable Air/Water Syringe Tips Copaliner Disposable Plastic Syringes Prehma HP Mixing Tips Prehma Prebent Mixing Tips Bosworth Disposable Plastic Syringes Bosworth HP Mixing Tips Bosworth Prebent Mixing Tips KeyPrint® KeyOrtho IBT™ Proform Keystone Prophybrite Air Polishing Unit Consistency VPS Impression Material Proform Blue Tray Proform Pink Baseplate Fastray Custom Tray Material Proform ProSplint Proform Splint KeyTray KeyDenture Try-In Bosworth Pit & Fissure Sealant with Fluoride Prehma Micro Applicators KeyGuide Bite Blocks Mizzy Dr. Clyde Schuyler Formula Wax Base Plate Wax Mizzy Dr. L.A. Cohn Formula Wax Mizzy Compound Cakes and Sticks Mizzy Byte Ryte Wax Mizzy Allcezon Wax

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2012-02-15
EFN Cotton, Roll Dental Class 1 872.6050 2012-05-31
EIH Powder, Porcelain Dental Class 2 872.6660 2014-10-29
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 2016-08-12
ELW Material, Impression Dental Class 2 872.3660 2016-01-21
MAU Eraser, Dental Stain Dental Class 1 872.6855 2012-06-05
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2015-12-14
NRD Unit, Operative Dental, Accessories Dental Class 1 872.6640 2012-06-05
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2025-07-02
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2012-06-05
EEA Plate, Base, Shellac Dental Class 1 872.6200 2008-11-12
EHZ Evacuator, Oral Cavity Dental Class 1 872.6640 2012-05-31
MQC Mouthguard, Prescription Unknown Class U N/A 2019-11-15
KMY Positioner, Tooth, Preformed Dental Class 1 872.5525 2019-11-15
EJW Clasp, Wire Dental Class 1 872.3285 2014-11-18
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2010-12-01
BTK Strap, Head, Gas Mask Anesthesiology Class 1 868.5560 2012-02-15
EFH Paper, Articulation Dental Class 1 872.6140 2006-02-24
EJP Articulators Dental Class 1 872.3150 2004-11-30
EHK Cup, Prophylaxis Dental Class 1 872.6290 2010-12-01
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2010-12-01
DZM Needle, Dental Dental Class 1 872.4730 2012-05-31
EJX Anchor, Preformed Dental Class 1 872.3130 2006-07-25
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2011-10-24
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2012-01-09
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2012-06-05
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-25
ELW Material, Impression Dental Class 2 872.3660 2014-05-29
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2015-12-14
EIE Dam, Rubber Dental Class 1 872.6300 2012-05-31
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2012-06-05
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2012-02-15
EMA Cement, Dental Dental Class 2 872.3275 2007-11-28
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2011-10-24
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2007-11-28
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 2016-01-21
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2014-05-29
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2010-12-01
DZN Instruments, Dental Hand Dental Class 1 872.4565 2010-12-01
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
LCN Scraper, Tongue Dental Class 1 872.6855 2010-12-01
DYN Mouthpiece, Saliva Ejector Dental Class 1 872.6640 2012-05-31
EJL Bur, Dental Dental Class 1 872.3240 2012-05-31
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2024-11-14
ECB Unit, Syringe, Air And/Or Water Dental Class 1 872.4565 2012-05-31
LBH Varnish, Cavity Dental Class 2 872.3260 2015-12-14
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 2012-05-31
QJJ Indirect Bonding Tray Dental Class 1 872.5410 2020-08-28
KMY Positioner, Tooth, Preformed Dental Class 1 872.5525 2021-12-17
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2015-12-10
ELW Material, Impression Dental Class 2 872.3660 2009-11-20
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 1995-12-26
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2015-12-14
KXR Applicator, Resin Dental Class 1 872.3140 2012-06-05
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2018-10-26
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2006-02-24

Official Correspondent

No official correspondent registered.

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
3010002722 Keystone Industries - Gibbstown Gibbstown, NJ, 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
K952614 Dentsply Intl. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 1996-08-13
K952662 Jeneric/Pentron, Inc. COMP=FLOW 1995-08-28

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0033-04 VIASYS Med Systems 1
Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04 VIASYS Med Systems 1
Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04 VIASYS Med Systems 1
Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04 VIASYS Med Systems 1
Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120
Z-0037-04 VIASYS Med Systems 1
Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2523320. Last updated year: 2026. Please use registration number 2523320 when referencing this establishment in official correspondence.
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