Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2938386

FEI Number

2938386

Entity Name

DenTek Oral Care, 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

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

Dental Applicator Boudreaux's Butt Brush The Doctor's Orapik Traveler Dentek Dental Scaler Dentek Oral Care Kit Dentek Dental Pick Dentek Wide Brush with Fluoride Dentek Easy Brush with Fluoride Dentek Sensitive Easy Brush Dentek Ready-Fit Dental Guards Dentek Custom Comfort Dental Guard Dentek Fresh Protect Dental Guard 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 Dentek Wax for Braces Comfort Fit Dental Guard DenTek Ultimate Dental Guard Dentek New Comfort-Fit Dental Guard Dentek Platinum Ultimate Comfort Dental Guard Dentek Easy Brush Tight Dentek Easy Brush Wide Dentek Slim Brush Dentek Dual Action Brush Dentek Deep Clean Bristle Picks Dentek Scrub Betweens Dentek Easy Brush Standard Dentek Easy Brush Sensitive Dentek Easy Brush The Doctor's Brushpicks

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2017-10-27
ELA	Instrument, Hand, Calculus Removal	Dental	Class 1	872.4565	2011-04-28
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	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
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2022-09-16
JES	Floss, Dental	Dental	Class 1	872.6390	2017-10-27
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	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	2018-11-16
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2017-10-27
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2017-10-27

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
1719513	MEDTECH PRODUCTS, INC.	Tarrytown, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2938386. Last updated year: 2026. Please use registration number 2938386 when referencing this establishment in official correspondence.