Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1719513

FEI Number

1719513

Entity Name

MEDTECH PRODUCTS, INC.

City/State/Country

Tarrytown, NY, US

Establishment Address

660 white plains rd, Tarrytown, NY 10591, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

PRESTIGE BRANDS HOLDINGS, INC. (Owner Number: 9057674)

Owner / Operator Contact Address

660 White Plains Rd, --, Tarrytown, NY 10591, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dentek New Comfort-Fit Dental Guard Dentek Platinum Ultimate Comfort Dental Guard Compound W Nitro-Freeze Compound W NitroFreeze XL Dentek Dental First Aid Kit Dentek Complete Dental Repair Kit Thin Set Cap and Crown Cement Temparin Max Hold Dentek Custom Comfort Dental Guard Dentek Maximum Protection Dental Guard Dentek Custom Comfort Dental Guard Dentek Wide Brush with Fluoride Dentek Easy Brush with Fluoride Dentek Sensitive Easy Brush The Doctor's Orapik Traveler Dentek Dental Scaler Dentek Oral Care Kit Dentek Dental Pick Stye Warming Eye Compress Comfort Clean Tongue Cleaner Orabrush Tongue Cleaner Dentek Tongue Cleaner Dentek Gum Stimulator Dentek Ultimate Comfort Picks Dentek Pocket Picks Comfort Fit Dental Guard COMPOUND W FREEZE-OFF WARTNER FREEZING WART REMOVER Compound W Freeze Off Plantar Wartner Plantar Nix Ultra Lotion Dentek Fresh & White Floss Picks Dentek Fresh Clean Floss Picks Dentek Triple Clean Floss Picks Dentek On-the-Go Floss Picks Dentek Complete Clean Back Teeth Floss Picks Dentek Floss Threader Dentek Comfort Clean Floss Picks Dentek Complete Clean Floss Picks Dentek Essentials Silk Floss Picks Dentek 3-in-1 Interdental Cleaners Dentek Kids Fun Flossers Dentek Sensitive Floss Picks Dentek Kids Fun Flosser Handle Dentek Comfort Clean Easy Reach Floss Picks Dentek Cross Flosser DenTek Fresh Breath Floss Pick Compound W Dual Power Compound W Nitro Freeze Skin Tag Remover Uristat Test Strips Compound W Freeze Off Advanced Compound W Freeze Off for Kids Compound W Gel plus Conseal Patch The Doctor's NightGuard Advanced Comfort Dentek Fresh Protect Dental Guard Efferdent Overnight Whitening Efferdent Denture Cleanser PM Efferdent Complete Clean Denture Cleanser Efferdent Coffee and Tea Efferdent Denture Cleanser Coffee and Tea Efferdent Denture Cleanser Original Efferdent Denture Cleanser Plus Efferdent Fresh and Clean Fresh Guard by Efferdent Soaks Dentek Wax for Braces Dentek Mouth Mirror Monistat Complete Care Vaginal Health Test Clear Eyes Contact Lens Relief Effergrip Denture Adhesive Efferdent Denture Bath Kit Little Remedies Nasal Syringe Murine Ear Syringe Debrox Ear Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2017-10-27
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2017-11-09
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2017-10-27
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2017-10-27
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2017-10-27
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2017-10-27
ELA	Instrument, Hand, Calculus Removal	Dental	Class 1	872.4565	2011-04-28
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2019-06-18
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2017-10-27
JET	Pick, Massaging	Dental	Class 1	872.6650	2007-12-14
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2017-10-27
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2006-12-28
LJL	Detectors And Removers, Lice, (Including Combs)	General Hospital	Class 1	880.5960	2021-04-13
JES	Floss, Dental	Dental	Class 1	872.6390	2017-10-27
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2017-01-27
ORE	N/A	N/A	Class N/A	N/A	2025-07-22
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2025-07-22
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2020-02-10
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2020-02-10
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2015-01-07
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2021-01-05
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2011-04-28
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2022-09-16
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2011-04-28
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2017-10-27
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2017-10-27
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2017-03-23
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2008-01-21
KOO	Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt	Dental	Class 1	872.3490	2022-01-20
JER	Cleaner, Denture, Mechanical	Dental	Class 1	872.3530	2021-04-13
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2021-04-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PRESTIGE BRANDS HOLDINGS, 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
2938386	DenTek Oral Care, Inc.	Tarrytown, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190651	Erbe Elektromedizin GmbH	ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter	2020-01-07
K760953	Spembly Medical , Ltd.	DEEP FREEZE SYSTEM (DFS-30)	1976-11-16
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-05	Ciba Vision Corporation	2	SOLO-care Plus with Aqualube, Multi-purpose solution* AquaSoft (Private label), Multi-purpose solutionSterile**For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.
Z-0129-2011	Abbott Medical Optics Inc (AMO)	2	AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.
Z-0130-2011	Abbott Medical Optics Inc (AMO)	2	AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml). Relieves the dryness, irritation, and discomfort that may be associated with contact lens wear.

Similar Registrations

Registration Number	Establishment Name	Location
3030268763	OWL DENTAL	San Leandro, CA, US
3029913483	DIMEDI KOREA INC	Busan, KR
3015525101	MIDWEST TEK	New Albany, IN, US
1825660	RANIR LLC	Grand Rapids, MI, US
3015128224	DOC BRANDS, INC.	Knoxville, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1719513. Last updated year: 2026. Please use registration number 1719513 when referencing this establishment in official correspondence.