FDA Registration
Active
🇺🇸 United States
DenTek Oral Care, Inc.
Reg #: 2938386
·
FEI: 2938386
·
Expires 2026
Products
11
Proprietary Names
56
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- DenTek Oral Care, Inc.
- Registration Number
- 2938386
- FEI Number
- 2938386
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 660 white plains rd, --
- City
- Tarrytown
- State
- NY
- ZIP
- 10591
- Country
- US
Regulatory Submissions
- 510(k) Number
- K130186
Owner / Operator
- Firm Name
- PRESTIGE BRANDS HOLDINGS, INC.
- Operator Number
- 9057674
- Address
- 660 White Plains Rd, --
- City
- Tarrytown
- State
- NY
- Postal Code
- 10591
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2017-10-27 |
| Instrument, Hand, Calculus Removal | ELA | Class 1 | Dental | No | 2011-04-28 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2017-10-27 |
| Mouthguard, Over-The-Counter | OBR | Class U | Unknown | No | 2017-10-27 |
| Floss, Dental | JES | Class 1 | Dental | No | 2017-10-27 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2017-10-27 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2017-10-27 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2017-10-27 |
| Oral Wound Dressing | OLR | Class U | Unknown | No | 2021-01-05 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2017-10-27 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2007-12-14 |
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
Dentek Maximum Protection Dental Guard
Comfort Clean Tongue Cleaner
Orabrush Tongue Cleaner
Dentek Tongue Cleaner
Dentek Mouth Mirror
Dentek Canker Relief
Dentek Dental First Aid Kit
Dentek Complete Dental Repair Kit
Thin Set Cap and Crown Cement
Temparin Max Hold
Dentek Gum Stimulator
Dentek Ultimate Comfort Picks
Dentek Pocket Picks
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198