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Data / Medical devices / United States / Keystone Industries

Keystone Industries: FDA-registered device maker in Myerstown, PA, United States, 26 510(k) clearances

Keystone Industries is registered with the FDA (registration 2523320) in Myerstown, PA, United States. It lists 50 device types. The FDA files 26 510(k) clearances under its listings, the newest dated May 20, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Keystone Industries
FDA registration number
2523320
Address
52 West King St, Myerstown, PA, United States, 17067
Owner or operator
Keystone Industries (9007845)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
December 26, 1995
Registered through
2026
Brand names listed
Base Plate Wax, Big Bite Trays, Bite Blocks, BoTrays disposable impression trays, Bosworth Acid Etch, Bosworth Disposable Plastic Syringes, Bosworth HP Mixing Tips, Bosworth Pit & Fissure Sealant with Fluoride and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Manufactureraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Manufactureraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Repackager or relabeleraccessdata.fda.gov
Anchor, PreformedEJX1Repackager or relabeleraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Repackager or relabeleraccessdata.fda.gov
Applicator, ResinKXR1Repackager or relabeleraccessdata.fda.gov
ArticulatorsEJP1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Blade, ScalpelGES1Repackager or relabeleraccessdata.fda.gov
Bur, DentalEJL1Repackager or relabeleraccessdata.fda.gov
Cement, DentalEMA2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Repackager or relabeleraccessdata.fda.gov
Clasp, PreformedEHP1Repackager or relabeleraccessdata.fda.gov
Clasp, WireEJW1Repackager or relabeleraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Specification developeraccessdata.fda.gov
Cotton, RollEFN1Repackager or relabeleraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cup, ProphylaxisEHK1Repackager or relabeleraccessdata.fda.gov
Dam, RubberEIE1Repackager or relabeleraccessdata.fda.gov
Eraser, Dental StainMAU1Manufactureraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Repackager or relabeleraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Repackager or relabeleraccessdata.fda.gov
Indirect Bonding TrayQJJ1Manufactureraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Repackager or relabeleraccessdata.fda.gov
Mask, SurgicalFXX2Repackager or relabeleraccessdata.fda.gov
Material, ImpressionELW2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Manufactureraccessdata.fda.gov
Mouthguard, PrescriptionMQCUManufactureraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Repackager or relabeleraccessdata.fda.gov
Needle, DentalDZM1Repackager or relabeleraccessdata.fda.gov
Paper, ArticulationEFH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Plate, Base, ShellacEEA1Manufactureraccessdata.fda.gov
Positioner, Tooth, PreformedKMY1Complaint file establishment, Manufactureraccessdata.fda.gov
Powder, PorcelainEIH2Repackager or relabeleraccessdata.fda.gov
Protector, SilicateEFX1Manufactureraccessdata.fda.gov
Resin, Denture, Relining, Repairing, RebasingEBI2Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Scraper, TongueLCN1Repackager or relabeleraccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Repackager or relabeleraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Repackager or relabeleraccessdata.fda.gov
Strap, Head, Gas MaskBTK1Repackager or relabeleraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Repackager or relabeleraccessdata.fda.gov
Tray, Fluoride, DisposableKMT1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Repackager or relabeleraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Repackager or relabeleraccessdata.fda.gov
Varnish, CavityLBH2Repackager or relabeleraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Specification developeraccessdata.fda.gov
Wrap, SterilizationFRG2Repackager or relabeleraccessdata.fda.gov
Zinc Oxide EugenolEMB1Manufacturer, Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 20, 2025K250489FP3DEBISubstantially EquivalentKeystone Industriesaccessdata.fda.gov
October 24, 2024K241089KeyPrint KeyDenture BaseEBISubstantially EquivalentKeystone Industriesaccessdata.fda.gov
April 9, 2021K203000KeyPrint KeySplint HardMQCSubstantially EquivalentMycone Dental Supply Co. Inc. (Dba Keystone Industries)accessdata.fda.gov
November 15, 2019K183598KeyPrint KeySplint SoftMQCSubstantially EquivalentKeystone Industriesaccessdata.fda.gov
April 27, 2018K172764KeymillEBISubstantially EquivalentMycone Dental Supply Company, Inc. (Aka Keystone Industries)accessdata.fda.gov
March 22, 2016K152051ClearMetEBISubstantially EquivalentMycone Dental Supply Co., T/A Keystone Industriesaccessdata.fda.gov
July 17, 2013K123787GREENCROSS SURGICAL MASKFXXSubstantially EquivalentJingzhou Haixin Green Cross Medical Products Co.,Laccessdata.fda.gov
December 7, 2011K112597SEITY 37% PHOSPHORIC ACID ETCHANT GELKLESubstantially EquivalentMycone Dental Supply Co., Inc.accessdata.fda.gov
December 3, 2010K100731BOSWORTH AIR POLISHEREFBSubstantially EquivalentHarry J. Bosworth Co.accessdata.fda.gov
December 27, 2007K071886SELF SEAL STERILIZATION POUCHFRGSubstantially EquivalentShanghai Jianzhong Medical Packaging Co., Ltd.accessdata.fda.gov
April 26, 2006K060377DR DISPOSABLE PROPHY ANGLE MODEL H310EGSSubstantially EquivalentDental Resourcesaccessdata.fda.gov
October 26, 2004K042048GELATO PROPHYLAXIS PASTEEJRSubstantially EquivalentDeepak Products, Inc.accessdata.fda.gov
May 14, 2004K041028CROWN DELTA HYDROPHILIC IMPRESSION MATERIALELWSubstantially EquivalentCrown Delta Corp.accessdata.fda.gov
September 23, 2003K032773DIAMOND D HIGH IMPACT DENTURE ACRYLICEBISubstantially EquivalentMycone Dental Supply Co., Inc.accessdata.fda.gov
September 4, 2003K031811PIT & FISSURE SEALANT WITH FLUORIDEEBCSubstantially EquivalentHarry J. Bosworth Co.accessdata.fda.gov
March 27, 2003K030859NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAINEIHSubstantially EquivalentEnamelite, LLCaccessdata.fda.gov
November 14, 2001K012882BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060EBISubstantially EquivalentThermoelastic Technologies, Inc.accessdata.fda.gov
December 16, 1998K983876MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLICEBISubstantially EquivalentMycone Dental Supply Co., Inc. (A/K/A Keystone Indaccessdata.fda.gov
December 10, 1998K983752ALUMINA-ZINC OXIDE POWDERS F AND REMASubstantially EquivalentHarry J. Bosworth Co.accessdata.fda.gov
November 3, 1998K981691SILICONE SOFT RELINEEBISubstantially EquivalentHarry J. Bosworth Co.accessdata.fda.gov
June 25, 1996K961199BOSWORTH TEMPORARY RESINEBGSubstantially EquivalentHarry J. Bosworth Co.accessdata.fda.gov
March 28, 1994K940402SUPERGEL/SUPPRESSED DUSTELWSubstantially EquivalentHarry J. Bosworth Co.accessdata.fda.gov
January 7, 1994K933505BOSWORTH COPALIONERLBHSubstantially EquivalentHarry J. Bosworth Co.accessdata.fda.gov
January 7, 1994K930248VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEMELWSubstantially EquivalentCrown Delta Corp.accessdata.fda.gov
February 10, 1987K864757MODIFIED VINYLAC PRESS PACK DENTURE RESINEBISubstantially EquivalentAstron Dental Corp.accessdata.fda.gov
July 8, 1980K801380CROWN DELTA SILICONE IMPRESSION MATERIALELWSubstantially EquivalentCrown Delta Corp.accessdata.fda.gov

Compare with other makers

Updated May 20, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.