TongueVǎge

Our story

Built on a simple belief

That oral care has been incomplete for too long — and that one overlooked step can change everything.

Our mission

Closing the gap in oral hygiene

For decades, oral care has focused on two surfaces: teeth and gums. Yet the tongue — the largest surface in the mouth and the primary reservoir for odour-causing bacteria — has been almost entirely ignored by mainstream oral care.

TongueVǎge was created to close that gap. We set out to engineer a device that takes the clinical science of tongue cleaning seriously: precision geometry, medical-grade materials, and a form factor that makes the habit effortless enough to sustain.

Our goal is not to sell a product. It is to shift a behaviour — to make tongue cleaning as automatic as brushing, and to give people the full picture of what a healthy mouth actually requires.

TongueVǎge team working on product design

What we stand for

Science first

Every design decision is grounded in peer-reviewed research. We do not make claims we cannot support, and we do not add features that do not serve the science.

Honest education

We believe people make better choices when they understand the why. Our role is to explain the biology clearly — not to create anxiety or manufacture urgency.

Purposeful design

Good design removes friction. TongueVǎge is engineered to be so easy and effective that skipping it feels like the odd choice.

Long-term thinking

We are building a brand for people who take their health seriously over the long term — not chasing trends or making promises that expire.

Who we are

A team that takes oral health seriously

TongueVǎge was founded by a team of product designers, oral health researchers, and wellness advocates who shared a frustration: the science on tongue cleaning was clear, but no one had built a device worthy of it. We changed that.

Regulatory pathway

FDA

01

Classification

Management intends to pursue the appropriate FDA regulatory pathway before commercial launch. Based on its intended function, TongueVǎge™ may qualify as a low-risk Class I device, a 510(k)-exempt device, or may require a traditional 510(k) premarket notification, depending on FDA classification and intended-use language. If a 510(k) submission is required, management will seek FDA clearance by demonstrating substantial equivalence to one or more legally marketed predicate devices, such as Nãvage, a comparable oral irrigation / suction-based device.

02

Process

Once the appropriate regulatory pathway is confirmed, management will work with a qualified medical-device regulatory consultant to prepare the FDA submission, establish quality-system procedures, finalize labeling and marketing claims, and ensure ongoing compliance with applicable FDA requirements.

03

Estimated cost

Management estimates that obtaining professional regulatory guidance and preparing an FDA submission for TongueVǎge™ could cost approximately $25,000 depending on the final FDA classification, predicate-device analysis, required testing, and whether a traditional 510(k) submission is required.