Inter-Med, Inc.
Racine, WI, US
INTER-MED, INC. appears in FDA device records in Racine, WI. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Inter-Med, Inc. between 1984 and 2026. The busiest year on record is 1987, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1985 | 1 |
| 1987 | 2 |
| 2009 | 1 |
| 2011 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253337 | REGEN Bioactive Cement | EMA | Substantially Equivalent | |
| K241489 | ReminGel | LBH | Substantially Equivalent | |
| K241457 | Vista BC Putty | KIF | Substantially Equivalent | |
| K241354 | Sealer Solvent | KJJ | Substantially Equivalent | |
| K221811 | Vista BC Sealer | KIF | Substantially Equivalent | |
| K211721 | PS System | NYL | Substantially Equivalent | |
| K112250 | CHX=CHX PLUS | KJJ | Substantially Equivalent | |
| K082470 | SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA | KJJ | Substantially Equivalent | |
| K871291 | AM CATH ESWL STENT | FAD | Substantially Equivalent | |
| K864669 | AM CATH ESWL STENT | FAD | Substantially Equivalent | |
| K851922 | URETERAL STONE DISLODGER | FFL | Substantially Equivalent | |
| K833058 | GEN. PURPOSE INSTRUMENT TRAYS & | FSM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2133714 | 3000209941 | INTER-MED, INC. | 2200 South St, Racine, WI 53404 US | 2026 | and 35 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EBZActivator, Ultraviolet, For Polymerization
- KLEAgent, Tooth Bonding, Resin
- KXFApplicator, Absorbent Tipped, Non-Sterile
- KXRApplicator, Resin
- EJLBur, Dental
- EKICarrier, Amalgam, Operative
- EMACement, Dental
- KJJCleanser, Root Canal
- QGOComposite Resin Warmer
- MVLCord, Retraction
- JSHCulture Media, Non-Selective And Differential
- EMKCurette, Surgical, Dental
- EIEDam, Rubber
- PEMDental Barriers And Sleeves
- LFCDevice, Caries Detection
- FFLDislodger, Stone, Basket, Ureteral, Metal
- KYXDispenser, Liquid Medication
- EHZEvacuator, Oral Cavity
- PMEExternal Cleaning Solution
- EFBHandpiece, Air-Powered, Dental
- NYLHandpiece, Air-Powered, Root Canal Irrigation
- EGZHolder, Film, X-Ray
- DZNInstruments, Dental Hand
- EBFMaterial, Tooth Shade, Resin
- KFCMethylene Blue, Tissue Stain
- EAXMirror, Mouth
- DYNMouthpiece, Saliva Ejector
- JETPick, Massaging
- EKRPlugger, Root Canal, Endodontic
- EKQPreparer, Root Canal Endodontic
- EISRemover, Crown
- EBIResin, Denture, Relining, Repairing, Rebasing
- KIFResin, Root Canal Filling
- LFDSaliva, Artificial
- EMNScaler, Periodontic
- EIRScissors, Collar And Crown
- LCNScraper, Tongue
- EBCSealant, Pit And Fissure, And Conditioner
- FADStent, Ureteral
- EICSyringe, Periodontic, Endodontic, Irrigating
- EIDSyringe, Restorative And Impression Material
- JEWTip, Rubber, Oral Hygiene
- KMTTray, Fluoride, Disposable
- EHYTray, Impression, Preformed
- FSMTray, Surgical, Instrument
- EFSUnit, Oral Irrigation
- ECBUnit, Syringe, Air And/Or Water
- LBHVarnish, Cavity
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2400-2026 | Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28 | Some 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 induce vomiting. | Class II | Open, Classified | |
| Z-0017-2020 | Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850 | The 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. | Class II | Terminated | |
| Z-0016-2020 | Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825 | The 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. | Class II | Terminated | |
| Z-0015-2020 | Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355 | The 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. | Class II | Terminated | |
| Z-0014-2020 | Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350 | The 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. | Class II | Terminated | |
| Z-0013-2020 | Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315 | The 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. | Class II | Terminated | |
| Z-0012-2020 | Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300 | The 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. | Class II | Terminated | |
| Z-0011-2020 | Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700 | The 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain