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Data / Medical devices / United States / Inter-Med, Inc.

Inter-Med, Inc.: FDA-registered device maker in Racine, WI, United States, 43 510(k) clearances

Inter-Med, Inc. is registered with the FDA (registration 2133714) in Racine, WI, United States. It lists 47 device types. The FDA files 43 510(k) clearances under its listings, the newest dated April 15, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Inter-Med, Inc.
FDA registration number
2133714
FEI number
3000209941
Address
2200 South St, Racine, WI, United States, 53404
Owner or operator
INTER-MED, INC. (9025886)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed
May 7, 1996
Registered through
2027
Brand names listed
3% Sodium Hypochlorite, 6% Sodium Hypochlorite, Air/Water Syringe Tips, Anchor, Appli-Vac, Aspirator / Valve Cleaning Brush, Astra Syringe, Autoclavable Replacement Heads and more

Devices it lists

DeviceProduct codeClassRoleSource
Activator, Ultraviolet, For PolymerizationEBZ2Specification developeraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Specification developeraccessdata.fda.gov
Applicator, ResinKXR1Repackager or relabeler, Specification developeraccessdata.fda.gov
Bur, DentalEJL1Repackager or relabeleraccessdata.fda.gov
Carrier, Amalgam, OperativeEKI1Manufacturer, Specification developeraccessdata.fda.gov
Cement, DentalEMA2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cleanser, Root CanalKJJUManufactureraccessdata.fda.gov
Composite Resin WarmerQGO1Manufactureraccessdata.fda.gov
Cord, RetractionMVLUManufacturer, Repackager or relabeleraccessdata.fda.gov
Culture Media, Non-Selective And DifferentialJSH1Manufactureraccessdata.fda.gov
Curette, Surgical, DentalEMK1Repackager or relabeler, Specification developeraccessdata.fda.gov
Dam, RubberEIE1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dental Barriers And SleevesPEM2Repackager or relabeleraccessdata.fda.gov
Device, Caries DetectionLFC2Repackager or relabeleraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Specification developeraccessdata.fda.gov
Dressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicMGQUManufactureraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Specification developeraccessdata.fda.gov
External Cleaning SolutionPME2Manufactureraccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Manufactureraccessdata.fda.gov
Handpiece, Air-Powered, Root Canal IrrigationNYL1Complaint file establishment, Manufactureraccessdata.fda.gov
Holder, Film, X-RayEGZ1Repackager or relabeler, Specification developeraccessdata.fda.gov
Instruments, Dental HandDZN1Manufactureraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Methylene Blue, Tissue StainKFC1Manufacturer, Specification developeraccessdata.fda.gov
Mirror, MouthEAX1Specification developeraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Repackager or relabeler, Specification developeraccessdata.fda.gov
Oral Wound DressingOLRUManufactureraccessdata.fda.gov
Pick, MassagingJET1Manufactureraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Repackager or relabeler, Specification developeraccessdata.fda.gov
Preparer, Root Canal EndodonticEKQ1Manufactureraccessdata.fda.gov
Remover, CrownEIS1Repackager or relabeler, Specification developeraccessdata.fda.gov
Resin, Denture, Relining, Repairing, RebasingEBI2Manufactureraccessdata.fda.gov
Resin, Root Canal FillingKIF2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Saliva, ArtificialLFDUManufactureraccessdata.fda.gov
Scaler, PeriodonticEMN1Repackager or relabeler, Specification developeraccessdata.fda.gov
Scissors, Collar And CrownEIR1Repackager or relabeleraccessdata.fda.gov
Scraper, TongueLCN1Repackager or relabeler, Specification developeraccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Manufactureraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Specification developeraccessdata.fda.gov
Tip, Rubber, Oral HygieneJEW1Specification developeraccessdata.fda.gov
Tray, Fluoride, DisposableKMT1Specification developeraccessdata.fda.gov
Tray, Impression, PreformedEHY1Specification developeraccessdata.fda.gov
Unit, Oral IrrigationEFS1Specification developeraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Repackager or relabeler, Specification developeraccessdata.fda.gov
Varnish, CavityLBH2Complaint file establishment, Specification developeraccessdata.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
April 15, 2026K253337REGEN Bioactive CementEMASubstantially EquivalentInter-Med, Inc.accessdata.fda.gov
January 8, 2025K241489ReminGelLBHSubstantially EquivalentInter-Med, Inc.accessdata.fda.gov
August 28, 2024K241457Vista BC PuttyKIFSubstantially EquivalentInter-Med, Inc.accessdata.fda.gov
August 27, 2024K241354Sealer SolventKJJSubstantially EquivalentInter-Med, Inc.accessdata.fda.gov
November 21, 2022K221811Vista BC SealerKIFSubstantially EquivalentInter-Med, Inc.accessdata.fda.gov
December 2, 2021K211721PS SystemNYLSubstantially EquivalentInter-Med, Inc.accessdata.fda.gov
October 23, 2020K193357V-MixKJJSubstantially EquivalentInter-Med/Vista Dental Productsaccessdata.fda.gov
September 9, 2020K193409Vista Rinse, Vista Rinse PlusKJJSubstantially EquivalentInter-Med/Vista Dental Productsaccessdata.fda.gov
May 27, 2020K193336Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound RinseOLRSubstantially EquivalentSynedgen, Inc.accessdata.fda.gov
March 4, 2020K193389Vista ClearMVLSubstantially EquivalentInter-Med/Vista Dental Productsaccessdata.fda.gov
November 8, 2019K190998BA Pit & Fissure SealantEBCSubstantially EquivalentApex Dental Materials, Inc.accessdata.fda.gov
September 10, 2019K190484BH Medical Dental Barrier Sleeves and Barrier FilmPEMSubstantially EquivalentBh Medical Products Co., Ltd.accessdata.fda.gov
June 10, 2019K190220Vista FS, Vista FS LiquidMVLSubstantially EquivalentInter-Med/Vista Dental Productsaccessdata.fda.gov
May 3, 2018K171577Smartcord, Smartcord XMVLSubstantially EquivalentEastdent Co., Ltd.accessdata.fda.gov
March 19, 2018K173237Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral MistLFDSubstantially EquivalentSyendgen, Inc.accessdata.fda.gov
June 8, 2017K170101Valiant Curing LightEBZSubstantially EquivalentInter-Med/Vista Dental Productsaccessdata.fda.gov
March 17, 2017K161077RnD TE and RnD SEKLESubstantially EquivalentApex Dental Materials, Inc.accessdata.fda.gov
September 10, 2013K131043APEX UNIVERSAL ADHESIVEKLESubstantially EquivalentApex Dental Materials, Inc.accessdata.fda.gov
August 27, 2013K131049ZRPKLESubstantially EquivalentApex Dental Materials, Inc.accessdata.fda.gov
May 31, 2012K120620CLEAN AND BOOSTKLESubstantially EquivalentApex Dental Materials, Inc.accessdata.fda.gov
October 28, 2011K112250CHX=CHX PLUSKJJSubstantially EquivalentInter-Med, Inc.accessdata.fda.gov
November 23, 2010K102254DMP SINGLE BONDINGKLESubstantially EquivalentDmp, Ltd.accessdata.fda.gov
October 1, 2009K092539SEAMFREEEBFSubstantially EquivalentApex Dental Materials, Inc.accessdata.fda.gov
September 21, 2009K091647INJECTAFILEBFSubstantially EquivalentApex Dental Materials, Inc.accessdata.fda.gov
April 3, 2009K082470SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRAKJJSubstantially EquivalentInter-Med, Inc.accessdata.fda.gov
October 13, 2006K062157CONFORMEBFSubstantially EquivalentApex Dental Materials, Inc.accessdata.fda.gov
July 31, 2006K061981SURPASSKLESubstantially EquivalentApex Dental Materials, Inc.accessdata.fda.gov
February 1, 2006K053103INTERFACEKLESubstantially EquivalentApex Dental Materials, Inc.accessdata.fda.gov
May 3, 2002K020760STARFLOW HVEBFSubstantially EquivalentDanville Materials, Inc.accessdata.fda.gov
April 24, 2002K020570SIMPLICITYKLESubstantially EquivalentApex Dental Materials, Inc.accessdata.fda.gov
January 25, 2002K013881RIBBOND - TRIAXIALEBISubstantially EquivalentRibbond, Inc.accessdata.fda.gov
September 14, 2001K010849VERTEX ETCHANTEBFSubstantially EquivalentApex Dental Materials, Inc.accessdata.fda.gov
June 11, 2001K011431RESIN CEMEMASubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
February 26, 1999K984503ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000KLESubstantially EquivalentWallace A. Erickson & Co.accessdata.fda.gov
January 20, 1999K984484LC MICROHYBRIDEBFSubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
September 10, 1997K972376IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USEEFBSubstantially EquivalentGlenwood, LLCaccessdata.fda.gov
September 10, 1997K972375IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USEEFBSubstantially EquivalentGlenwood, LLCaccessdata.fda.gov
December 6, 1996K963922ALPHA-DENT ROOT CANAL SEALER & FILLERKIFSubstantially EquivalentWallace A. Erickson & Co.accessdata.fda.gov
August 6, 1996K952927IMPACT AIR 45 4-HOLEEFBSubstantially EquivalentPalisades Pharmaceutics, Inc.accessdata.fda.gov
February 8, 1996K955445CARIES FINDERLFCSubstantially EquivalentDanville Engineering, Inc.accessdata.fda.gov
January 26, 1994K933766HIGH-Q-BONDEBFSubstantially EquivalentSilmet U.S.A. Corp.accessdata.fda.gov
October 7, 1991K913040RIBBOND(TM)EBISubstantially EquivalentRibbond, Inc.accessdata.fda.gov
May 28, 1980K801216DEN-MAT DENTIN BONDING AGENTKLESubstantially EquivalentDen-Mat Corp.accessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
May 27, 202699105Class IIOngoingAdvance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to inaccessdata.fda.gov
June 27, 201983435Class IITerminatedVista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.accessdata.fda.gov

Compare with other makers

Updated June 10, 2026. 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.