Data / Medical devices / United States / Medtech Products, Inc.
Medtech Products, Inc.: FDA-registered device maker in Tarrytown, NY, United States, 20 510(k) clearances and 1 PMA approval
Medtech Products, Inc. is registered with the FDA (registration 1719513) in Tarrytown, NY, United States. It lists 29 device types. The FDA files 20 510(k) clearances and 1 PMA approval under its listings, the newest dated November 6, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1719513
- Address
- 660 white plains rd, Tarrytown, NY, United States, 10591
- Owner or operator
- PRESTIGE BRANDS HOLDINGS, INC. (9057674)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 28, 2006
- Registered through
- 2026
- Brand names listed
- Boudreaux's Butt Brush, Breathe Right Nasal Strips, Breathe Right Sparkling Saline Nasal Rinse Spray, COMPOUND W FREEZE-OFF, Clear Eyes Contact Lens Relief, Comfort Clean Tongue Cleaner, Comfort Fit Dental Guard, Compound W Complete Wart Kit and more
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 6, 2024 | K242803 | Compound W Skin Tag Remover | GEH | Substantially Equivalent | Medtech Products, Inc. | accessdata.fda.gov |
| October 18, 2024 | K240226 | Pixie Skin Tag | ORE | Substantially Equivalent | Oystershell NV | accessdata.fda.gov |
| December 22, 2020 | K202974 | DenTek Fresh Protect Dental Guard | OBR | Substantially Equivalent | Medtech Products, Inc. | accessdata.fda.gov |
| September 17, 2018 | K180933 | DenTek Ultimate Dental Guard | OBR | Substantially Equivalent | Medtech Products, Inc. | accessdata.fda.gov |
| August 17, 2018 | K181074 | Simple Science Antimicrobial Facial and Eyelid Cleanser | FRO | Substantially Equivalent | Simple Science, LLC | accessdata.fda.gov |
| November 2, 2017 | K172373 | Compound W Nitro-Freeze | GEH | Substantially Equivalent | Medtech Products, Inc. | accessdata.fda.gov |
| March 21, 2017 | K163401 | Nix Ultra Lice Treatment Kit | LJL | Substantially Equivalent | Medtech Products, Inc. | accessdata.fda.gov |
| September 15, 2016 | K161294 | Compound W Wart Removal System Dual Power | GEH | Substantially Equivalent | Medtech Products, Inc. | accessdata.fda.gov |
| September 30, 2015 | K151149 | Ready-Fit | OBR | Substantially Equivalent | Den Tek Oral Care, Inc. | accessdata.fda.gov |
| August 14, 2015 | K151309 | Wartie Advanced Wart Remover or other proprietary name | GEH | Substantially Equivalent | Youmedical Corp BV | accessdata.fda.gov |
| June 12, 2014 | K140314 | WARTIE WART REMOVER | GEH | Substantially Equivalent | Yonmedical BV | accessdata.fda.gov |
| July 15, 2013 | K130186 | DENTEK EASY BRUSH WITH FLUORIDE | EFW | Substantially Equivalent | Den Tek Oral Care, Inc. | accessdata.fda.gov |
| January 10, 2013 | K123849 | NEW COMFORT-FIT DENTAL GUARD | OBR | Substantially Equivalent | Den Tek Oral Care, Inc. | accessdata.fda.gov |
| February 17, 2011 | K100024 | TECO DIAGNOSTICS UTI DETECTION STRIPS | JMT | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| June 12, 2009 | K091660 | CUSTOM COMFORT NIGHTGUARD VERSION 2 | OBR | Substantially Equivalent | Den Tek Oral Care, Inc. | accessdata.fda.gov |
| December 11, 2008 | K083400 | CUSTOM COMFORT NIGHTGUARD | OBR | Substantially Equivalent | Den Tek Oral Care, Inc. | accessdata.fda.gov |
| July 10, 2008 | K081669 | IMPROVED COMFORT-FIT NIGHTGUARD | OBR | Substantially Equivalent | Den Tek Oral Care, Inc. | accessdata.fda.gov |
| December 19, 2007 | K073220 | THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT | OBR | Substantially Equivalent | Prestige Brands, Inc. | accessdata.fda.gov |
| March 3, 2006 | K053580 | DOCTOR'S NIGHTGUARD | MQC | Substantially Equivalent | Dental Concepts, LLC | accessdata.fda.gov |
| September 10, 2003 | K032271 | WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022) | GEH | Substantially Equivalent | Wartner USA B.V. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 13, 1989 | P880056 | MURINER LUBRICATING & REWETTING DROPS | LPN | 2 | April 14, 1994 | accessdata.fda.gov |
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Updated November 6, 2024. 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.