Manufacturer registered with FDA
Inter-Med, Inc.
Racine, WI, United States. Lists 37 dental device types with FDA across 3 registered establishments, and holds 7 510(k) clearances as applicant.
- Device types listed
- 37
- Brands and models
- 173
- 510(k) clearances
- 71991–2026
- Markets registered in
- 1232 registrations outside the US
- Establishments
- 3China, United States
510(k) clearances per year, 1990–2026
Registered in 12 markets
Where regulators' registries name Inter-Med, Inc. 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 | Inter-Med, Inc. | 7 clearances | 1991–2026 | Below |
| European Union | EUDAMED | Manufacturer | INTERMED SRLRibbond, Inc. | 8 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Inter-Med, Inc.INTER-MED, INC. · RIBBOND, INC. · +1 | 6 | 2011–2025 | Pure Global AI |
| Canada | Health Canada | Registration holder | RIBBOND, INC. | 4 | 1999–2008 | Pure Global AI |
| Israel | AMAR | Manufacturer | Inter-Med, Inc.Ribbond, Inc. | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Ribbond Inc | 2 | 2005–2023 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | RIBBOND, INCRibbond Inc | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Ribbond, Inc. | 2 | 1999–2011 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Ribbond, Inc. | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | RIBBOND, INC | 1 | 2017–2017 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | RIBBOND, INC | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | RIBBOND, INC. | 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 Inter-Med, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | BondsaverBondsaver DClean and BoostClean and Boost GelDesensiMAXInjectafilInterfaceRegen Bulk Fill Composite and Resin CementRegen CleanserRegen Self Etch Adhesive 7 moreRegen Universal AdhesiveSimplicitySuperbSurpassVista Best EtchZirconia PrimerZr-P | 2018 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Exquisite RestorationInjectafilRegen Bulk Fill Composite and Resin CementRegen Flowable Composite LinerSeamfreeTitanVelvet EtchVista Porcelain Etch, Vista Silane | 2011 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | RibbondRibbond-Triaxial | 2025 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Impact Air 45 | 2021 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | RE-GEN Bioactive EndosealerREGEN Bioactive EndoPuttyVista-Cal | 2015 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Vista Disposable HVE Screens | 2014 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Disposable Mouth MirrorsMetal Mirror StemMouth Mirrors | 2007 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Air/Water Syringe TipsEZ-Lock AdapterPrecision IrrigatorSYRINGE TIP COVER | 1997 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | — | 1997 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Impression Tray | 2007 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Aspirator / Valve Cleaning BrushAutoclavable Replacement HeadsElasti-Vac & Pre-Bent Elasti-VacEndodontic AspiratorFrazier AspiratorHigh Speed Suction ValveHIGH VOLUME EVACUATIONHVE ScreensMicro AspiratorStraw Aspirator 4 moreSurgical EvacuatorSurgical No-ClogVENTED/NON-VENTEDVista Low Speed Saliva Ejector Valve w/ Heads | 2007 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Appli-VacColored SyringeDriplessExacta-FloFlexi-GlideIRRIGATINGMicro-EvacNiTi SuperFlexProbeSecure Lock Appli-Vac 5 moreSecure Lock Vista ProbeUtility SyringeVisco TipVisco Tip AssemblyVoyager | 2007 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | DISPOSABLE IMPRESSION SYRINGETherma-Flo Composite ApplicatorTherma-Flo Step-Down Tips | 1997 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Maker | Ribbond Scissors | 2025 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | MTA CARRIER | 2006 |
| Dental CementEMA · Class 2 | Dental cements | Maker | AnchorREGEN Bioactive Cement | 2019 |
| Oral Hygiene Rubber TipJEW · Class 1 | Floss & interdental cleaners | Maker | Pocket Probe Assembly | 2014 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | Fluoride Tray | 2007 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Bendable tipBlue FloComposite BrushComposite Brush HandleCotton Tipped ApplicatorFine Micro-Applicator BrushLong Shank BrushesPre-bent Tip (16ga, 20ga, 22ga, 25ga)Pre-bent Tip with Material Saving Technology (22ga)Regular Micro-Applicator Brush 6 moreSol-u-FloSpiral-Flo Brush TipsStat-FloVista Micro Flowthru Brush Tip (20ga, 22ga, 25ga)Vista Ultra-Fine Micro-Applicator BrushVolu-Flo | 2012 |
| Tongue ScraperLCN · Class 1 | — | Maker | TONGUE SCRAPER | 1997 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Vista-Pak packing instrument, circlet, plain tipVista-Pak packing instrument, circlet, serrated tipVista-Pak packing instrument, standard, plain tipVista-Pak packing instrument, standard, serrated tip | 2012 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | REGEN Pit & Fissure Sealant | 2020 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | PinkWavePinkWave PaddlePinkWave Tacking TipsValiant | 2017 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Vista Bite Wing Tabs | 2011 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Blue Gingival BarrierLiquid Dam | 2005 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | Vista PRT Endodontic Tip | 2014 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | Impact Air 45 Surgical Bur | 2022 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | Citric AcidEndoUltra Tip Kit 15/02Rinse-N-DryVersa BrushVista GE20 Endodontic TipVista GE20D Endodontic TipVista GE40 Endodontic TipVista GE40D Endodontic TipVista GEBD-1 Endodontic TipVista GEBD-2 Endodontic Tip 5 moreVista GEFD-1 Endodontic TipVista GEFD-2 Endodontic TipVista SET20-4D Endodontic TipsVista SET40-4D Endodontic TipsVista UCT Endodontic Tip | 2000 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Vista CT4 TipVista CT7 Tip | 2014 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | Vista S70 Apical Surgery TipVista S70D Apical Surgery TipVista S90 Apical Surgery TipVista S90D Apical Surgery TipVista SA Apical Surgery TipVista SAD Apical Surgery TipVista SML Apical Surgery TipVista SMLD Apical Surgery TipVista SMR Apical Surgery TipVista SMRD Apical Surgery Tip 4 moreVista SPL Apical Surgery TipVista SPLD Apical Surgery TipVista SPR Apical Surgery TipVista SPRD Apical Surgery Tip | 2014 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Tip WrenchVista #31 Special Periodontal TipVista #33 L Special Periodontal TipVista #33 R Special Periodontal TipVista #33 Universal Periodontal TipVista #37 Periodontal TipVista #37L Special Periodontal TipVista #37R Special Periodontal TipVista #39 Periodontal TipVista HA Periodontal Tip 14 moreVista HC Periodontal TipVista HFL Periodontal TipVista HFR Periodontal TipVista PS2 TipVista PS6 TipVista PTL Periodontal TipVista PTR Periodontal TipVista PTU Periodontal TipVista SU1 General Scaling TipVista SU2 General Scaling TipVista SU3 General Scaling TipVista SU4 General Scaling TipVista SU5 General Scaling TipVista SU6 General Scaling Tip | 2014 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | EndoUltra Kit | 2014 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | ReminGel | 2025 |
| Caries Detection DeviceLFC · Class 2 | Caries detection devices | Lister | Caries Red and Green | 2013 |
| Root Canal Irrigation Air-Powered HandpieceNYL · Class 1 | — | Maker | Pulpsucker (PS) System | 2022 |
| External Cleaning SolutionPME · Class 2 | — | Maker | ZrC | 2021 |
| Composite Resin WarmerQGO · Class 1 | — | Maker | PhasorTherma-Flo Composite WarmerTherma-Flo Syringe WarmerVisCalor | 2020 |
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 Inter-Med, Inc. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 15 Apr 2026 | K253337 | REGEN Bioactive Cement | EMA Dental Cement |
| 8 Jan 2025 | K241489 | ReminGel | LBH Cavity Varnish |
| 28 Aug 2024 | K241457 | Vista BC Putty | KIF Root Canal Filling Resin |
| 21 Nov 2022 | K221811 | Vista BC Sealer | KIF Root Canal Filling Resin |
| 2 Dec 2021 | K211721 | PS System | NYL Root Canal Irrigation Air-Powered Handpiece |
| 25 Jan 2002 | K013881 | RIBBOND - TRIAXIAL | EBI Rebasing Repairing Relining Denture Resin |
| 7 Oct 1991 | K913040 | RIBBOND(TM) | EBI Rebasing Repairing Relining Denture Resin |
Also lists devices cleared under other names
Inter-Med, Inc. 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: Apex Dental Materials, Inc. (12), S & C Polymer GmbH (2), Wallace A. Erickson & Co. (2), Glenwood, LLC (2), Inter-Med/Vista Dental Products (1), Dmp, Ltd. (1), Danville Materials, LLC (1), Palisades Pharmaceutics, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 8 Nov 2019 | K190998 | BA Pit & Fissure Sealant | Apex Dental Materials, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 8 Jun 2017 | K170101 | Valiant Curing Light | Inter-Med/Vista Dental Products | EBZ Ultraviolet Activator for Polymerization |
| 17 Mar 2017 | K161077 | RnD TE and RnD SE | Apex Dental Materials, Inc. | KLE Resin Tooth Bonding Agent |
| 10 Sep 2013 | K131043 | APEX UNIVERSAL ADHESIVE | Apex Dental Materials, Inc. | KLE Resin Tooth Bonding Agent |
| 27 Aug 2013 | K131049 | ZRP | Apex Dental Materials, Inc. | KLE Resin Tooth Bonding Agent |
| 31 May 2012 | K120620 | CLEAN AND BOOST | Apex Dental Materials, Inc. | KLE Resin Tooth Bonding Agent |
| 23 Nov 2010 | K102254 | DMP SINGLE BONDING | Dmp, Ltd. | KLE Resin Tooth Bonding Agent |
| 1 Oct 2009 | K092539 | SEAMFREE | Apex Dental Materials, Inc. | EBF Resin Tooth Shade Material |
| 21 Sep 2009 | K091647 | INJECTAFIL | Apex Dental Materials, Inc. | EBF Resin Tooth Shade Material |
| 13 Oct 2006 | K062157 | CONFORM | Apex Dental Materials, Inc. | EBF Resin Tooth Shade Material |
| 31 Jul 2006 | K061981 | SURPASS | Apex Dental Materials, Inc. | KLE Resin Tooth Bonding Agent |
| 1 Feb 2006 | K053103 | INTERFACE | Apex Dental Materials, Inc. | KLE Resin Tooth Bonding Agent |
| 3 May 2002 | K020760 | STARFLOW HV | Danville Materials, LLC | EBF Resin Tooth Shade Material |
| 24 Apr 2002 | K020570 | SIMPLICITY | Apex Dental Materials, Inc. | KLE Resin Tooth Bonding Agent |
| 14 Sep 2001 | K010849 | VERTEX ETCHANT | Apex Dental Materials, Inc. | EBF Resin Tooth Shade Material |
| 11 Jun 2001 | K011431 | RESIN CEM | S & C Polymer GmbH | EMA Dental Cement |
| 26 Feb 1999 | K984503 | ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 | Wallace A. Erickson & Co. | KLE Resin Tooth Bonding Agent |
| 20 Jan 1999 | K984484 | LC MICROHYBRID | S & C Polymer GmbH | EBF Resin Tooth Shade Material |
| 10 Sep 1997 | K972375 | IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE | Glenwood, LLC | EFB Dental Air-Powered Handpiece |
| 10 Sep 1997 | K972376 | IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE | Glenwood, LLC | EFB Dental Air-Powered Handpiece |
| 6 Dec 1996 | K963922 | ALPHA-DENT ROOT CANAL SEALER & FILLER | Wallace A. Erickson & Co. | KIF Root Canal Filling Resin |
| 6 Aug 1996 | K952927 | IMPACT AIR 45 4-HOLE | Palisades Pharmaceutics, Inc. | EFB Dental Air-Powered Handpiece |
| 8 Feb 1996 | K955445 | CARIES FINDER | Danville Engineering, Inc. | LFC Caries Detection Device |
| 26 Jan 1994 | K933766 | HIGH-Q-BOND | Silmet U.S.A. Corp. | EBF Resin Tooth Shade Material |
| 28 May 1980 | K801216 | DEN-MAT DENTIN BONDING AGENT | Den-Mat Corp. | KLE Resin Tooth Bonding Agent |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| INTER-MED, INC.FDA reg. 2133714 | Racine, WI, United States | Complaint file establishment, Manufacturer, Repacker / relabeler, Specification developer |
| RIBBOND, INC.FDA reg. 3027616 | Racine, WI, United States | Manufacturer, Specification developer |
| SINO-VISTA DENTAL INSTRUMENTS CO., LTD.FDA reg. 3006608997 | Zibo Shandong, China | Contract manufacturer |
Other names on FDA records
Ribbond, Inc. · Sino-Vista Dental Instruments Co., Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9025886). 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.