Manufacturer registered with FDA
Prestige Brands Holdings, Inc.
Tarrytown, NY, United States. Lists 13 dental device types with FDA across 2 registered establishments, and holds 1 510(k) clearance as applicant.
- Device types listed
- 13
- Brands and models
- 58
- 510(k) clearances
- 12013–2013
- Markets registered in
- 716 registrations outside the US
- Establishments
- 2United States
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Prestige Brands Holdings, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Prestige Brands Holdings, Inc. | 1 clearances | 2013–2013 | Below |
| Brazil | ANVISA | Manufacturer | MEDTECH PRODUCTS INC.dentek oral care inc | 4 | 2014–2018 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Dentek Oral Care Limited | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | DenTek Oral Care, Inc.DenTek Oral Care,Inc. | 3 | 2018–2019 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DENTEK ORAL CARE INC | 2 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | DenTek Oral Care Limited | 2 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | DENTEK ORAL CARE, INC. | 1 | 2013–2013 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Prestige Brands Holdings, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Dentek Deep Clean Bristle PicksDentek Dual Action BrushDentek Easy BrushDentek Easy Brush SensitiveDentek Easy Brush StandardDentek Easy Brush TightDentek Easy Brush WideDentek Easy Brush with FluorideDentek Scrub BetweensDentek Sensitive Easy Brush 3 moreDentek Slim BrushDentek Wide Brush with FluorideThe Doctor's Brushpicks | 2017 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Dentek Mouth Mirror | 2017 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Dentek Wax for Braces | 2017 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Maker | Dentek Dental PickDentek Dental ScalerDentek Oral Care KitThe Doctor's Orapik Traveler | 2011 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | Dentek Complete Dental Repair KitDentek Dental First Aid KitTemparin Max HoldThin Set Cap and Crown Cement | 2017 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dentek 3-in-1 Interdental CleanersDentek Comfort Clean Easy Reach Floss PicksDentek Comfort Clean Floss PicksDentek Complete Clean Back Teeth Floss PicksDentek Complete Clean Floss PicksDentek Cross FlosserDentek Essentials Silk Floss PicksDentek Floss ThreaderDentek Fresh & White Floss PicksDenTek Fresh Breath Floss Pick 6 moreDentek Fresh Clean Floss PicksDentek Kids Fun Flosser HandleDentek Kids Fun FlossersDentek On-the-Go Floss PicksDentek Sensitive Floss PicksDentek Triple Clean Floss Picks | 2017 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Dentek Gum StimulatorDentek Pocket PicksDentek Ultimate Comfort Picks | 2007 |
| Tongue ScraperLCN · Class 1 | — | Maker | Comfort Clean Tongue CleanerDentek Tongue CleanerOrabrush Tongue Cleaner | 2017 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Efferdent Coffee and TeaEfferdent Complete Clean Denture CleanserEfferdent Denture Cleanser Coffee and TeaEfferdent Denture Cleanser OriginalEfferdent Denture Cleanser PlusEfferdent Denture Cleanser PMEfferdent Fresh and CleanEfferdent Overnight WhiteningFresh Guard by Efferdent Soaks | 2011 |
| Mechanical Denture CleanerJER · Class 1 | Denture cleansers & adhesives | Maker | Efferdent Denture Bath Kit | 2021 |
| Carboxymethylcellulose Sodium (32%) and Ethylene-Oxide Homopolymer Denture AdhesiveKOL · Class 1 | — | Maker | Effergrip | 2011 |
| Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt Denture AdhesiveKOO · Class 1 | Denture cleansers & adhesives | Maker | Effergrip Denture Adhesive | 2022 |
| Over the Counter Wax Impregnated Cotton Denture Pad CushionNKJ · Class 1 | — | Maker | EZO Denture Cushions (Upper and Lower) | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Prestige Brands Holdings, Inc. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 15 Jul 2013 | K130186 | DENTEK EASY BRUSH WITH FLUORIDE | EFW Manual Toothbrush |
Some of these clearances are listed with FDA today by another company: Global Dent Aids Pvt. Ltd. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DenTek Oral Care, Inc.FDA reg. 2938386 | Tarrytown, NY, United States | Specification developer |
| MEDTECH PRODUCTS, INC.FDA reg. 1719513 | Tarrytown, NY, United States | Complaint file establishment, Specification developer |
Other names on FDA records
Dentek Oral Care Limited · Medtech Products Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9057674). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.