Data / Medical devices / United States / DenTek Oral Care, Inc.
DenTek Oral Care, Inc.: FDA-registered device maker in Tarrytown, NY, United States, 9 510(k) clearances
DenTek Oral Care, Inc. is registered with the FDA (registration 2938386) in Tarrytown, NY, United States. It lists 11 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 22, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2938386
- 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 14, 2007
- Registered through
- 2026
- Brand names listed
- Boudreaux's Butt Brush, Comfort Clean Tongue Cleaner, Comfort Fit Dental Guard, DenTek Fresh Breath Floss Pick, DenTek Ultimate Dental Guard, Dental Applicator, Dentek 3-in-1 Interdental Cleaners, Dentek Canker Relief and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Specification developer | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Specification developer | accessdata.fda.gov |
| Instrument, Hand, Calculus Removal | ELA | 1 | Specification developer | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Specification developer | accessdata.fda.gov |
| Mouthguard, Over-The-Counter | OBR | U | Specification developer | accessdata.fda.gov |
| Oral Wound Dressing | OLR | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Specification developer | accessdata.fda.gov |
| Scraper, Tongue | LCN | 1 | Specification developer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Specification developer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Specification developer | accessdata.fda.gov |
| Zinc Oxide Eugenol | EMB | 1 | Specification developer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| December 22, 2020 | K202974 | DenTek Fresh Protect Dental Guard | OBR | Substantially Equivalent | Medtech Products, Inc. | accessdata.fda.gov |
| September 18, 2019 | K183436 | OraCure | OLR | Substantially Equivalent | Tbm Corporation | accessdata.fda.gov |
| September 17, 2018 | K180933 | DenTek Ultimate Dental Guard | OBR | 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 |
| 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 |
| 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 |
Compare with other makers
- All makers of Mouthguard, Over-The-Counter
- All makers of Wax, Dental, Intraoral
- All makers of Scraper, Tongue
- All makers of Toothbrush, Manual
- All makers of Instrument, Hand, Calculus Removal
- All makers of Pick, Massaging
Updated December 22, 2020. 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.