Data / Medical devices / United States / Mouthwatch, Inc.
Mouthwatch, Inc.: FDA-registered device maker in Metuchen, NJ, United States, 1 510(k) clearance
Mouthwatch, Inc. is registered with the FDA (registration 3012664306) in Metuchen, NJ, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 3, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012664306
- Address
- 20 Highland Ave, Metuchen, NJ, United States, 08840
- Owner or operator
- MouthWatch, LLC (10052230)
- Roles
- Specification developer
- First device listed
- July 1, 2016
- Registered through
- 2026
- Brand names listed
- Dentistry.One Tongue Scraper, MouthWatch Intraoral Camera, MouthWatch Plus+ Intraoral Camera, One.Brush, OptiClear Intraoral Camera Sleeves, OptiClear Sleeves
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dental Barriers And Sleeves | PEM | 2 | Specification developer | accessdata.fda.gov |
| Scraper, Tongue | LCN | 1 | Specification developer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Specification developer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 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 |
|---|---|---|---|---|---|---|
| August 3, 2021 | K211026 | Minitube Dentasleeve Protective Barrier Sleeves | PEM | Substantially Equivalent | Minitube AB | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Operative Dental, Accessories
- All makers of Toothbrush, Powered
- All makers of Scraper, Tongue
- All makers of Dental Barriers And Sleeves
Updated August 3, 2021. 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.