FDA Registration
Active
🇺🇸 United States
INTER-MED, INC.
Reg #: 2133714
·
FEI: 3000209941
·
Expires 2026
Products
45
Proprietary Names
197
Establishment Types
4
Classifications
45
Registration Details
- Registration Name
- INTER-MED, INC.
- Registration Number
- 2133714
- FEI Number
- 3000209941
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2200 South St
- City
- Racine
- State
- WI
- ZIP
- 53404
- Country
- US
Regulatory Submissions
- 510(k) Number
- K972375
Owner / Operator
- Firm Name
- INTER-MED, INC.
- Operator Number
- 9025886
- Address
- 2200 South Street, --
- City
- Racine
- State
- WI
- Postal Code
- 53404
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2021-12-01 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2014-09-24 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2007-08-02 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2007-08-02 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2017-06-19 |
| Handpiece, Air-Powered, Root Canal Irrigation | NYL | Class 1 | Dental | No | 2022-07-20 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2019-12-16 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2019-12-16 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2020-01-14 |
| Tray, Fluoride, Disposable | KMT | Class 1 | Dental | No | 2007-08-02 |
| Cord, Retraction | MVL | Class U | Unknown | No | 2020-07-28 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2025-09-30 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2014-07-31 |
| Composite Resin Warmer | QGO | Class 1 | Dental | No | 2020-12-12 |
| Carrier, Amalgam, Operative | EKI | Class 1 | Dental | No | 2006-09-01 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 1997-05-13 |
| External Cleaning Solution | PME | Class 2 | Dental | No | 2021-11-23 |
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2021-01-29 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2014-07-31 |
| Tip, Rubber, Oral Hygiene | JEW | Class 1 | Dental | No | 2014-07-31 |
| Saliva, Artificial | LFD | Class U | Unknown | No | 2026-03-23 |
| Scissors, Collar And Crown | EIR | Class 1 | Dental | No | 2025-12-17 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2023-04-06 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2007-08-02 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2005-01-13 |
| Cleanser, Root Canal | KJJ | Class U | Unknown | No | 2021-01-29 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2025-12-17 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2007-08-02 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2014-07-31 |
| Culture Media, Non-Selective And Differential | JSH | Class 1 | Microbiology | No | 2025-09-17 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 1997-02-05 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 1997-12-02 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 1996-05-07 |
| Device, Caries Detection | LFC | Class 2 | Dental | No | 2013-09-05 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2019-12-16 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2012-11-02 |
| Methylene Blue, Tissue Stain | KFC | Class 1 | Hematology | No | 2003-08-07 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2012-11-14 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2007-08-02 |
| Remover, Crown | EIS | Class 1 | Dental | No | 2014-07-31 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2022-02-08 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2014-08-15 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2011-06-16 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 1997-06-16 |
| Preparer, Root Canal Endodontic | EKQ | Class 1 | Dental | No | 2000-12-26 |
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
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
Clean and Boost
Regen Cleanser
Clean and Boost Gel
Ribbond-Triaxial
Anchor
Vista-Pak packing instrument, circlet, plain tip
Vista-Pak packing instrument, standard, serrated tip
Vista-Pak packing instrument, standard, plain tip
Vista-Pak packing instrument, circlet, serrated tip
VISTA BLUE
Vista Micro Flowthru Brush Tip (20ga, 22ga, 25ga)
Regular Micro-Applicator Brush
Vista Ultra-Fine Micro-Applicator Brush
Fine Micro-Applicator Brush
Pre-bent Tip (16ga, 20ga, 22ga, 25ga)
Composite Brush Handle
Long Shank Brushes
Pre-bent Tip with Material Saving Technology (22ga)
Composite Brush
Cotton Tipped Applicator
Volu-Flo
Sol-u-Flo
Bendable tip
Stat-Flo
Blue Flo
Spiral-Flo Brush Tips
VENTED/NON-VENTED
Autoclavable Replacement Heads
Vista Low Speed Saliva Ejector Valve w/ Heads
HVE Screens
High Speed Suction Valve
Micro Aspirator
Aspirator / Valve Cleaning Brush
Surgical No-Clog
Straw Aspirator
Surgical Evacuator
Endodontic Aspirator
Frazier Aspirator
Elasti-Vac & Pre-Bent Elasti-Vac
HIGH VOLUME EVACUATION
REGEN Bioactive EndoPutty
Vista PRT Endodontic Tip
Titan
Regen Flowable Composite Liner
Regen Self Etch Adhesive
Surpass
Impact Air 45 Surgical Bur
Injectafil
Regen Bulk Fill Composite and Resin Cement
EndoUltra Kit
Vista Bite Wing Tabs
Therma-Flo Composite Applicator
DISPOSABLE IMPRESSION SYRINGE
Therma-Flo Step-Down Tips
Rinse-N-Dry
EndoUltra Tip Kit 15/02
Vista GEFD-1 Endodontic Tip
Vista GE40 Endodontic Tip
Vista GEBD-2 Endodontic Tip
Vista SET40-4D Endodontic Tips
Vista SET20-4D Endodontic Tips
Vista GE40D Endodontic Tip
Vista GEFD-2 Endodontic Tip
Vista UCT Endodontic Tip
Vista GEBD-1 Endodontic Tip
Vista GE20D Endodontic Tip
Vista GE20 Endodontic Tip
Citric Acid
Versa Brush
Zirconia Primer
Zr-P
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198