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Data / Medical devices / United States / Keystone Industries - Gibbstown

Keystone Industries - Gibbstown: FDA-registered device maker in Gibbstown, NJ, United States, 14 510(k) clearances

Keystone Industries - Gibbstown is registered with the FDA (registration 3010002722) in Gibbstown, NJ, United States. It lists 17 device types. The FDA files 14 510(k) clearances under its listings, the newest dated October 24, 2024. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Keystone Industries - Gibbstown
FDA registration number
3010002722
Address
480 S Democrat Rd, Gibbstown, NJ, United States, 08027
Owner or operator
Keystone Industries (9007845)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
December 26, 1995
Registered through
2026
Brand names listed
Big Bite Trays, BoTrays disposable impression trays, Bosworth Acid Etch, Bosworth Pit & Fissure Sealant with Fluoride, Bosworth Prophy Powder, Copaliner, Cora-Caine, Dentusil and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Complaint file establishment, Manufactureraccessdata.fda.gov
Adhesive, Denture, KarayaKOP1Manufactureraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Manufactureraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Contract manufacturer, Manufactureraccessdata.fda.gov
Cement, DentalEMA2Manufactureraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Contract manufactureraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Manufactureraccessdata.fda.gov
Indirect Bonding TrayQJJ1Complaint file establishment, Manufactureraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Manufactureraccessdata.fda.gov
Mouthguard, PrescriptionMQCUComplaint file establishment, Manufactureraccessdata.fda.gov
Plate, Base, ShellacEEA1Manufactureraccessdata.fda.gov
Positioner, Tooth, PreformedKMY1Complaint file establishment, Manufactureraccessdata.fda.gov
Powder, PorcelainEIH2Contract manufacturer, Manufactureraccessdata.fda.gov
Resin, Denture, Relining, Repairing, RebasingEBI2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Manufactureraccessdata.fda.gov
Tray, Impression, PreformedEHY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Varnish, CavityLBH2Manufactureraccessdata.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
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
December 7, 2011K112597SEITY 37% PHOSPHORIC ACID ETCHANT GELKLESubstantially EquivalentMycone Dental Supply Co., Inc.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
January 7, 1994K933505BOSWORTH COPALIONERLBHSubstantially EquivalentHarry J. Bosworth Co.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
November 20, 202393522Class IIOngoingKeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).accessdata.fda.gov
July 21, 202392851Class IIOngoingKeystone Bosworth Copaliner Cavity Varnish.5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).accessdata.fda.gov
April 10, 202392856Class IIOngoingHenry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.:The Hard Line Chairside Reline Kit ) (0921940HS) was labeled as Soft Line Chairside Reline Kit ) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly labeled as Hard Line materialsaccessdata.fda.gov

Compare with other makers

Updated October 24, 2024. 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.