INTER-MED, INC.

FDA Device Registration & Listing · Racine, WI, US · Registration 2133714

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2133714
FEI Number
3000209941
Entity Name
INTER-MED, INC.
City/State/Country
Racine, WI, US
Establishment Address
2200 South St, Racine, WI 53404, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
INTER-MED, INC. (Owner Number: 9025886)
Owner / Operator Contact Address
2200 South Street, --, Racine, WI 53404, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K955445
PMA Number
N/A

All Registered Proprietary Names

Impact Air 45 Vista Disposable HVE Screens Impression Tray Visco Tip Assembly Dripless Flexi-Glide Exacta-Flo Appli-Vac Probe Visco Tip Secure Lock Vista Probe Secure Lock Appli-Vac NiTi SuperFlex Utility Syringe Colored Syringe Micro-Evac Voyager IRRIGATING Valiant PinkWave PinkWave Paddle PinkWave Tacking Tips Pulpsucker (PS) System Seamfree Regen Universal Adhesive Superb REGEN Pit & Fissure Sealant Fluoride Tray Interface Quick Stat Free ReminGel Vista SA Apical Surgery Tip Vista S90D Apical Surgery Tip Vista SMLD Apical Surgery Tip Vista SPLD Apical Surgery Tip Vista SPRD Apical Surgery Tip Vista S90 Apical Surgery Tip Vista SMRD Apical Surgery Tip Vista SPR Apical Surgery Tip Vista SML Apical Surgery Tip Vista S70 Apical Surgery Tip Vista S70D Apical Surgery Tip Vista SMR Apical Surgery Tip Vista SAD Apical Surgery Tip Vista SPL Apical Surgery Tip Phasor Therma-Flo Syringe Warmer Therma-Flo Composite Warmer VisCalor MTA CARRIER TONGUE SCRAPER ZrC Exquisite Restoration Velvet Etch Simplicity Stat-Pak Stat-Pack+E EndoUltra Barrier Sleeves Phasor Barrier Sleeves Curing Light Barrier Sleeves Vista #37 Periodontal Tip Vista #33 L Special Periodontal Tip Vista HFR Periodontal Tip Vista SU6 General Scaling Tip Vista #33 Universal Periodontal Tip Vista SU1 General Scaling Tip Vista SU4 General Scaling Tip Vista SU3 General Scaling Tip Vista PTU Periodontal Tip Vista PTR Periodontal Tip Vista HFL Periodontal Tip Vista SU5 General Scaling Tip Vista #37R Special Periodontal Tip Vista #37L Special Periodontal Tip Vista HC Periodontal Tip Vista PTL Periodontal Tip Vista #39 Periodontal Tip Vista SU2 General Scaling Tip Vista PS2 Tip Vista #33 R Special Periodontal Tip Vista #31 Special Periodontal Tip Vista HA Periodontal Tip Vista PS6 Tip Tip Wrench Pocket Probe Assembly Moisyn Ribbond Scissors Impact Air 45 DesensiMAX Bondsaver Bondsaver D RE-GEN Bioactive Endosealer Cotton-Tipped Applicators Quick-Stat Liquid Quick-Stat Gel Liquid Dam Blue Gingival Barrier Triton Endo Sealer Solvent CanalPro CHX-Ultra CHX and CHX-Plus Ribbond Mouth Mirrors Metal Mirror Stem Disposable Mouth Mirrors CanalPro NaOCl 6% NaOCl Extra CanalPro NaOCl 3% HypoPure HypoPure Pro 3% Sodium Hypochlorite 6% Sodium Hypochlorite Chlor-Xtra, Hypochlorite Solution EDTA SmearOFF Vista Best Etch Vista CT7 Tip Vista CT4 Tip Vista Porcelain Etch, Vista Silane Precision Irrigator Air/Water Syringe Tips EZ-Lock Adapter SYRINGE TIP COVER Vista-Cal Cooke-Waite Syringe Astra Syringe Caries Red and Green

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2021-12-01
DYN Mouthpiece, Saliva Ejector Dental Class 1 872.6640 2014-09-24
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2007-08-02
EIC Syringe, Periodontic, Endodontic, Irrigating Dental Class 1 872.4565 2007-08-02
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2017-06-19
NYL Handpiece, Air-Powered, Root Canal Irrigation Dental Class 1 872.4200 2022-07-20
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2019-12-16
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2019-12-16
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2020-01-14
KMT Tray, Fluoride, Disposable Dental Class 1 872.6870 2007-08-02
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2019-12-16
MVL Cord, Retraction Unknown Class U N/A 2020-07-28
LBH Varnish, Cavity Dental Class 2 872.3260 2025-09-30
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2026-05-19
EMK Curette, Surgical, Dental Dental Class 1 872.4565 2014-07-31
QGO Composite Resin Warmer Dental Class 1 872.6100 2020-12-12
EKI Carrier, Amalgam, Operative Dental Class 1 872.4565 2006-09-01
LCN Scraper, Tongue Dental Class 1 872.6855 1997-05-13
PME External Cleaning Solution Dental Class 2 872.3260 2021-11-23
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2020-11-06
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2020-04-15
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2019-12-16
MVL Cord, Retraction Unknown Class U N/A 2015-01-22
PEM Dental Barriers And Sleeves General, Plastic Surgery Class 2 878.4370 2021-01-29
EMN Scaler, Periodontic Dental Class 1 872.4565 2014-07-31
JEW Tip, Rubber, Oral Hygiene Dental Class 1 872.6650 2014-07-31
LFD Saliva, Artificial Unknown Class U N/A 2026-03-23
EIR Scissors, Collar And Crown Dental Class 1 872.4565 2025-12-17
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2021-12-01
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2019-12-16
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2023-04-06
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2007-08-02
MVL Cord, Retraction Unknown Class U N/A 2019-07-01
EIE Dam, Rubber Dental Class 1 872.6300 2005-01-13
KJJ Cleanser, Root Canal Unknown Class U N/A 2021-01-29
KJJ Cleanser, Root Canal Unknown Class U N/A 2024-11-14
KJJ Cleanser, Root Canal Unknown Class U N/A 2012-11-14
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2025-12-17
EAX Mirror, Mouth Dental Class 1 872.4565 2007-08-02
KJJ Cleanser, Root Canal Unknown Class U N/A 2009-04-06
KJJ Cleanser, Root Canal Unknown Class U N/A 2021-02-09
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2018-05-22
EKR Plugger, Root Canal, Endodontic Dental Class 1 872.4565 2014-07-31
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-06-16
JSH Culture Media, Non-Selective And Differential Microbiology Class 1 866.2320 2025-09-17
ECB Unit, Syringe, Air And/Or Water Dental Class 1 872.4565 1997-02-05
EFS Unit, Oral Irrigation Dental Class 1 872.6510 1997-12-02
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2015-01-14
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 1996-05-07
LFC Device, Caries Detection Dental Class 2 872.1740 2013-09-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INTER-MED, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3027616 RIBBOND, INC. Racine, WI, US
3006608997 SINO-VISTA DENTAL INSTRUMENTS CO., LTD. Zibo Shandong, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K212910 Shenzhen Carejoy Technology Co., Ltd. Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece 2022-11-17
K781592 Henry Schein, Inc. SURGICAL ASPIRATOR TIPS 1978-12-04
K243921 Foshan Coxo Medical Instrument Co., Ltd. LED Curing Lights (DB686 HALO) 2025-04-11
K033201 Apoza Enterprise Co., Ltd. LA500 BLUE LIGHT 2003-12-02
K952662 Jeneric/Pentron, Inc. COMP=FLOW 1995-08-28

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0011-2020 Inter-Med Llc U
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
Z-0012-2020 Inter-Med Llc U
Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Z-0013-2020 Inter-Med Llc U
Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
Z-0014-2020 Inter-Med Llc U
Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Z-0015-2020 Inter-Med Llc U
Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355
Z-0016-2020 Inter-Med Llc U
Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825
Z-0017-2020 Inter-Med Llc U
Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2133714. Last updated year: 2026. Please use registration number 2133714 when referencing this establishment in official correspondence.
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