Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012664306

FEI Number

3012664306

Entity Name

MOUTHWATCH, INC.

City/State/Country

Metuchen, NJ, US

Establishment Address

20 Highland Ave, Metuchen, NJ 08840, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MouthWatch, LLC (Owner Number: 10052230)

Owner / Operator Contact Address

460 Main Street, Ste B (Rear), Metuchen, NJ 08840, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211026

PMA Number

N/A

All Registered Proprietary Names

MouthWatch Intraoral Camera MouthWatch Plus+ Intraoral Camera OptiClear Sleeves OptiClear Intraoral Camera Sleeves

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2016-07-01
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2026-03-25

Official Correspondent

Brant Herman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MouthWatch, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012664306. Last updated year: 2026. Please use registration number 3012664306 when referencing this establishment in official correspondence.