Manufacturer registered with FDA
Keystone Industries
Gibbstown, NJ, United States. Lists 41 dental device types with FDA across 3 registered establishments, and holds 2 510(k) clearances as applicant.
- Device types listed
- 41
- Brands and models
- 120
- 510(k) clearances
- 22024–2025
- Markets registered in
- 12322 registrations outside the US
- Establishments
- 3United States
510(k) clearances per year, 2007–2026
Registered in 12 markets
Where regulators' registries name Keystone Industries as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Keystone Industries | 2 clearances | 2024–2025 | Below |
| European Union | EUDAMED | Manufacturer | Keystone Industries | 153 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | KEYSTONE INDUSTRIES | 68 | 1999–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Keystone IndustriesKEYSTONE INDUSTRIES · keystone industries | 28 | 2000–2015 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | KEYSTONE INDUSTRIESKeystone Industries | 19 | 2006–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Keystone Industries | 18 | 2004–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Keystone Industries | 13 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | KEYSTONE INDUSTRIES | 7 | 2019–2024 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Keystone Industries | 7 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Keystone Industries | 7 | 2024–2025 | Pure Global AI |
| China | NMPA | Registration holder | 基石实业Keystone Industries | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | KEYSTONE INDUSTRIES | 1 | 2023–2023 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Keystone Industries currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | ClearmetDentusilDiamond D Denture MaterialDuz-AllFP3DKeyDenture BaseKeymillKeyPrint KeySplint HardMillenniumNew Truliner 8 moreOriginal TrulinerProflexSledgehammerSoftoneTruRepairTrusoftUltra FastVersacryl Denture Material | 2007 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | KeyPrint KeySplint HardKeySplint SoftProform Splint and ProSplintProform Super Clear Retainer | 2019 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | TrimTrim II | 2015 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | Consistency Bite RegistrationConsistency PuttyConsistency VPS Impression MaterialPlastopasteSuperbiteSupergelSupergel FreshSuperpaste | 2009 |
| Dental CementEMA · Class 2 | Dental cements | Maker | Bosworth Zinc Phosphate CementMizzy Fleck's Zinc CementMizzy Polycarboxylate (PCA) Cement PowderSuperEBA | 2007 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Fastray Custom Tray MaterialKeyDenture Try-InKeyTrayProform Blue TrayProform Pink Baseplate | 1995 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Enamelite Ceramic Spray Glaze | 2014 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Bosworth Prophy PowderKeystone Gelato Prophy Paste | 2010 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | KeyGuide | 2018 |
| Indirect Bonding TrayQJJ · Class 1 | — | Maker | KeyPrint® KeyOrtho IBT | 2020 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | Bosworth Pit & Fissure Sealant with Fluoride | 2015 |
| Shellac Base PlateEEA · Class 1 | — | Maker | Versacryl sealant | 2008 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Big Bite TraysBoTrays disposable impression traysEdentulous Impression TraysPrehma Disposable Impression TraysPrehma Multi Bite Impression TraysStainless Steel TraysTray Adhesive Compound(TAC) Liquid and SprayTray Aways Disposable Impression trays | 2012 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Bosworth Acid EtchSeity Etchant Gel | 2012 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | Copaliner | 2015 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Lister | Flexo Disposable Saliva EjectorsPrehma Saliva Ejectors | 2012 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Lister | Prehma Disposable Dental Needles | 2012 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | Prehma Matrix Bands, Rolls & RetainersWonder Wedges Interproximal Wedges | 2010 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Lister | Prehma Disposable Air/Water Syringe Tips | 2012 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Lister | Prophybrite Air Polishing Unit | 2015 |
| Articulation PaperEFH · Class 1 | — | Maker | Mizzy PIP AerosolMizzy Pressure Indicating Paste (PIP)Prehma Articulating PaperPrehma Horseshoe Articulating Paper | 2006 |
| Roll CottonEFN · Class 1 | — | Lister | Prehma Cotton Rolls | 2012 |
| Silicate ProtectorEFX · Class 1 | — | Maker | Masque Silicone Lubricant & Separator | 2015 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Base Plate WaxBite BlocksMizzy Allcezon WaxMizzy Byte Ryte WaxMizzy Compound Cakes and SticksMizzy Dr. Clyde Schuyler Formula WaxMizzy Dr. L.A. Cohn Formula Wax | 2006 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | Fortis Disposable Prophy AnglesKeystone Disposable Prophy AnglesNero Disposable Prophy Angles | 2010 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | Keystone Industries Prophy CupPrehma Prophylaxis CupsPrehma Prophylaxis Polishing Brushes | 2010 |
| Preformed ClaspEHP · Class 1 | — | Lister | Itsoclear ClaspsKeystone Industries Wire Clasps | 2006 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Keystone HVE Tips | 2012 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | Bosworth Disposable Plastic SyringesBosworth HP Mixing TipsBosworth Prebent Mixing TipsDisposable Plastic Syringes | 2012 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Lister | Prehma Rubber Dam | 2012 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | Prehma Carbide Burs | 2012 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | Deluxe Magnetic ArticulatorKeystone ArticulatorsLuxury Articulator | 2004 |
| Wire ClaspEJW · Class 1 | — | Lister | Keystone Industries Clasp Wire | 2014 |
| Preformed AnchorEJX · Class 1 | — | Lister | Frego StrengthenerKeystone Industries Grid StrengthenersKeystone Industries Lingual BarsKeystone Industries Mesh StrengthenersKeystone Industries Twist Plate Strengtheners | 2006 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | Keystone EugenolKeystone Zinc Oxide PowderMizzy Z.O.E Cement | 2022 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | Gelato Disposable Fluoride TraysKeystone Industries Disposable Fluoride TraysMizzy Prevent Fluoride Trays | 2010 |
| Karaya Denture AdhesiveKOP · Class 1 | — | Maker | Cora-Caine | 2015 |
| Resin ApplicatorKXR · Class 1 | — | Lister | Prehma Micro Applicators | 2012 |
| Tongue ScraperLCN · Class 1 | — | Lister | Keystone Industries Tongue Scraper | 2010 |
| Dental Stain EraserMAU · Class 1 | — | Maker | NIU Bleaching Systems | 2012 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Lister | Prehma Barrier FilmPrehma Pro-Guard TowelsPrehma SleevesSimplastic Patient DrapeSimplastic SleevesSimplastic Tray CoverSimplastic Uni-Cover | 2012 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Keystone Industries as the applicant, including filings under its other names.
Also lists devices cleared under other names
Keystone Industries lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Harry J. Bosworth Co. (7), Crown Delta Corp. (3), Mycone Dental Supply Co., Inc. (2), Mycone Dental Supply Company, Inc. (Aka Keystone Industries) (1), Mycone Dental Supply Co., T/A Keystone Industries (1), Dental Resources (1), Deepak Products, Inc. (1), Enamelite, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 Apr 2018 | K172764 | Keymill | Mycone Dental Supply Company, Inc. (Aka Keystone Industries) | EBI Rebasing Repairing Relining Denture Resin |
| 22 Mar 2016 | K152051 | ClearMet | Mycone Dental Supply Co., T/A Keystone Industries | EBI Rebasing Repairing Relining Denture Resin |
| 7 Dec 2011 | K112597 | SEITY 37% PHOSPHORIC ACID ETCHANT GEL | Mycone Dental Supply Co., Inc. | KLE Resin Tooth Bonding Agent |
| 3 Dec 2010 | K100731 | BOSWORTH AIR POLISHER | Harry J. Bosworth Co. | EFB Dental Air-Powered Handpiece |
| 26 Apr 2006 | K060377 | DR DISPOSABLE PROPHY ANGLE MODEL H310 | Dental Resources | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 26 Oct 2004 | K042048 | GELATO PROPHYLAXIS PASTE | Deepak Products, Inc. | EJR Oral Cavity Abrasive Polishing Agent |
| 14 May 2004 | K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | Crown Delta Corp. | ELW Impression Material |
| 23 Sep 2003 | K032773 | DIAMOND D HIGH IMPACT DENTURE ACRYLIC | Mycone Dental Supply Co., Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 4 Sep 2003 | K031811 | PIT & FISSURE SEALANT WITH FLUORIDE | Harry J. Bosworth Co. | EBC Pit and Fissure Sealant and Conditioner |
| 27 Mar 2003 | K030859 | NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN | Enamelite, LLC | EIH Porcelain Powder |
| 14 Nov 2001 | K012882 | BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 | Thermoelastic Technologies, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 16 Dec 1998 | K983876 | MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC | Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind | EBI Rebasing Repairing Relining Denture Resin |
| 10 Dec 1998 | K983752 | ALUMINA-ZINC OXIDE POWDERS F AND R | Harry J. Bosworth Co. | EMA Dental Cement |
| 3 Nov 1998 | K981691 | SILICONE SOFT RELINE | Harry J. Bosworth Co. | EBI Rebasing Repairing Relining Denture Resin |
| 25 Jun 1996 | K961199 | BOSWORTH TEMPORARY RESIN | Harry J. Bosworth Co. | EBG Resin Temporary Crown and Bridge |
| 28 Mar 1994 | K940402 | SUPERGEL/SUPPRESSED DUST | Harry J. Bosworth Co. | ELW Impression Material |
| 7 Jan 1994 | K933505 | BOSWORTH COPALIONER | Harry J. Bosworth Co. | LBH Cavity Varnish |
| 7 Jan 1994 | K930248 | VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM | Crown Delta Corp. | ELW Impression Material |
| 10 Feb 1987 | K864757 | MODIFIED VINYLAC PRESS PACK DENTURE RESIN | Astron Dental Corporation | EBI Rebasing Repairing Relining Denture Resin |
| 8 Jul 1980 | K801380 | CROWN DELTA SILICONE IMPRESSION MATERIAL | Crown Delta Corp. | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Keystone IndustriesFDA reg. 2523320 | Myerstown, PA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
| Keystone IndustriesFDA reg. 2280629 | CHERRY HILL, NJ, United States | Manufacturer |
| Keystone Industries - GibbstownFDA reg. 3010002722 | Gibbstown, NJ, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repacker / relabeler |
Other names on FDA records
Keystone Industries - Gibbstown
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9007845). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.