Compliance by market: mouthguards, whitening kits and mouth tape

Anti-snoring mouthpieces and night guards are regulated as medical devices in the main export markets, and whitening gels as cosmetics. The tables below set out the class, the business roles and the documents for the United States, the European Union, Great Britain, Northern Ireland, Canada and Australia.

Each business holds the part of the file that goes with its role. Who makes the product, who develops the specification, who imports it, who puts its own brand on it and who sells it decides which business holds each document in each market, and that split is agreed before you order. Ask for material data, technical inputs or a test report against the exact quoted reference. No catalogue reference is sold with a clearance attached.

Classification by product and market

The class follows the intended use, formulation or construction, intended users and sales route. Great Britain (England, Scotland and Wales) and Northern Ireland are assessed separately.

Product	United States	European Union	Great Britain	Northern Ireland	Canada	Australia
Anti-snoring mouthpiece	Class II medical device, 21 CFR 872.5570, product code LRK. Cleared through a 510(k); whether a given device may be sold over the counter or only on prescription is set by the indications for use in its own clearance. The production company, Dongguan Yiyao Technology Development Co., Ltd. (named in the FDA record as Dongguan Yiyao Science & Technology Development Co., Ltd.), holds its own clearance, K250028, for models TD-02 and TD-03 (decision 3 October 2025), and an FDA establishment registration, number 3038209294; the FDA indications-for-use form specifies over-the-counter use for TD-02 and TD-03 (checked 9 September 2026). Confirm the exact supplied model, configuration and labelling against that record. Use the registration to identify the establishment and a device listing to check the devices and activities reported to FDA; neither is an approval or clearance, and neither alone shows that your branded product may be sold in the United States. Putting your brand on a device does not automatically require a new 510(k), and it does not automatically mean the existing clearance supports your version; before ordering, confirm the device, intended use, labelling and the responsibilities of each business in the supply chain.	Medical device under the device regulation. Ask your adviser to determine the class and conformity route for the exact device and intended duration under Rule 5. Confirm the authorised-representative and importer roles for the actual supply chain.	Assess under UK medical-device rules. Check the applicable UKCA or accepted CE route and its conditions; confirm MHRA registration and whether a UK Responsible Person is needed.	EU medical-device rules apply. Check CE conformity and whether an EU or Northern Ireland authorised representative is needed; UKCA is not accepted here.	Class I under the device rules for the oral cavity; confirm the applicable establishment-licence requirement and holder.	Medical device; Class I or IIa by duration of use; confirm whether register inclusion and an Australian sponsor are required.
Night guard for teeth grinding	Product code OBR, over-the-counter mouthguard, an unclassified device whose submission type is a 510(k). Ask for the applicable decision and exact product, label and business-role match.	Medical device; the same duration question as the mouthpiece.	Assess the exact device under the GB route above.	Assess the exact device under the Northern Ireland route above.	Class I under the oral-cavity rule; an "orthodontic appliance" reading would make it Class II, which is a question to settle with your adviser.	Class I or IIa; the register already carries occlusal-splint entries.
Sports mouthguard	No product code for a sports-only guard was established; the prescription-mouthguard code recognises the athletic mouth-protector standard. Confirm whether the exact guard is a children's product subject to a CPSC safety rule; if so, determine the applicable testing and certificate requirements. A youth label alone does not decide this.	Not a medical device: personal protective equipment, Category II, which needs type examination of a prototype by a notified body before CE marking.	Confirm whether protective-equipment rules apply, then the assessment body and marking route for GB.	Confirm whether EU protective-equipment rules apply and which assessment and marking route is needed in Northern Ireland.	Not established; most likely a consumer product outside the device rules.	Not established; most likely a consumer good with no therapeutic claim.
Whitening gel or pen	A cosmetic, unless it claims to change the structure or function of the teeth. Assess facility registration, product listing, exemptions and any US-agent requirement for the actual facility and responsible person. No federal percentage cap was found.	A cosmetic. Up to 0.1% hydrogen peroxide present or released for consumer sale; above 0.1% and up to 6% through dental practitioners only, first use under supervision; above 6% prohibited. A responsible person, a product information file and the notification before sale.	Assess the formulation and intended use under GB cosmetics rules; confirm the ingredient restrictions, UK-established Responsible Person, safety file and SCPN notification.	Assess under EU cosmetics rules; confirm ingredient restrictions, an EU or Northern Ireland Responsible Person, safety file and CPNP notification.	A cosmetic. The pH must be above 4.00; above 3% hydrogen peroxide equivalents needs a clinical study on salivary peroxide.	Under the poisons schedule: 3% to 6% hydrogen peroxide, or 9% to 18% carbamide peroxide, may be sold to consumers with prescribed warnings; above that, dental practitioners only.
LED whitening light	No product code or guidance was found; its status depends on the claims made for it. An emissions report is asked for.	A 5-volt USB light sits outside the low-voltage directive but inside the electromagnetic-compatibility and restricted-substances rules, with a declaration of conformity; the general product safety rules require a responsible person in the EU.	Identify the electrical and product-safety rules for the exact light, power supply and claims in GB.	Identify the applicable EU electrical and product-safety rules for the exact light, power supply and claims in Northern Ireland.	Consumer-product duties.	Consumer-product duties.
Mouth tape	Have your adviser assess intended use, construction and presentation before deciding the applicable route.	Assess whether consumer-product or device rules apply to this exact intended use and presentation.	Assess the intended use, construction and presentation under GB rules.	Assess the intended use, construction and presentation under the rules applicable in Northern Ireland.	Confirm the route for the exact product, intended use and claims.	Confirm the route for the exact product, intended use and claims.

Duration of use and the EU device class

In the EU, how long the device is worn decides its class. Your adviser records the intended duration, interruptions, replacement pattern and oral-cavity rule for the exact device. The EU classification guidance distinguishes interrupted from discontinued use; the seller cannot choose a class by counting only one night or adding up every night. Assess Great Britain, Northern Ireland and Australia separately. For the European Union, see MDCG 2021-24 Rev.1.

Business roles and documents by market

Duties follow what each business actually does; a brand name or sales invoice does not settle its legal role.

Market	Role questions	Documents and duties to assess	Technical inputs to request
United States	Which businesses make, specify, relabel, repack or initially import the device? Which facility and responsible person handle a cosmetic?	Determine applicable clearance, registration and listing duties by activity, including exemptions; confirm any US-agent requirement.	Finished-article test inputs, material declarations, gel assay and production records; agree the exact scope first.
European Union	For the chosen device, cosmetic or consumer-product route, who acts as manufacturer, importer, authorised representative or responsible person?	Confirm which roles, technical or safety files, conformity assessment and notifications apply to the exact product and supply chain, including a notified-body certificate where the class needs one.	Material and formulation data; agreed laboratory reports and technical inputs.
Great Britain	For devices, is the manufacturer outside the UK and therefore required to appoint a UK Responsible Person? For cosmetics, identify the UK-established Responsible Person.	Confirm the applicable device registration and conformity route, or the cosmetic safety file and SCPN notification. Assess other products separately.	Technical inputs for the agreed GB scope.
Northern Ireland	For devices, identify any EU or Northern Ireland authorised representative needed. For cosmetics, identify the EU or Northern Ireland Responsible Person.	Confirm EU device conformity and current registration requirements, or the cosmetic safety file and CPNP notification. Assess other products separately.	Technical inputs for the agreed Northern Ireland scope.
Canada	Which business imports or distributes the exact product, and under which product regime?	Confirm any establishment or device licence, cosmetic notification, formulation limits and supporting data required for that role and product.	Material and assay data; formulation disclosure.
Australia	Does the exact product require a sponsor, and which business takes that role?	Confirm any register inclusion, conformity documentation, poisons-schedule labelling and other applicable product duties.	Material and assay data.

GB and Northern Ireland distinctions and US role questions checked on 8 September 2026: MHRA device guidance, GB cosmetics guidance, Northern Ireland cosmetics guidance, FDA device activity table, FDA cosmetics registration and exemptions, and CPSC certificate requirements.

Claims regulators and marketplaces reject

Keep these claims off listings and packaging. Each of these has been rejected by a regulator or a marketplace, or contradicts how the product is classified.

That the agency in the United States has approved a mouthguard, a mouthpiece or a gel. Devices of this kind are cleared, not approved; cosmetics are neither.
That a registration or a listing is an endorsement. It means only that a facility notified the agency.
That the company-level record or a document for another product establishes the regulatory status of your branded version.
That a mouthpiece addresses any sleep condition, or that any product of this kind is for one. That claim needs clinical sleep-study data in a cleared file.
That a product ends snoring, ends grinding, or protects against concussion.
That a dentist or a dental association endorses the product, unless you hold that endorsement in writing.
That a material is free of a named substance, or is of a named grade, without the test report behind it.
That one peroxide percentage is safe for home use worldwide. The limits differ by market.
That a peroxide-free active is approved in the EU. It is unlisted, and its safety rests on your safety report.
That mouth tape has any effect on a sleep condition.
That a product carries a device-certification badge with no market, class or holder named.

Packaging wording

Packaging wording comes from the verified material, construction, kit contents and controlled instructions for the exact reference; your adviser assesses intended use, claims and labelling together. Construction wording is not a regulatory exemption, and the company-level FDA record does not identify a catalogue reference.

Primary sources by product

Settle the duration question for Europe, the UK and Australia with your adviser.
Read the EU cosmetic annex entry for hydrogen peroxide in its own words for the gel you want.
Read the United States regulation for intraoral anti-snoring devices in its own words.
Read your marketplace's live policy page for the category from inside your seller account; the marketplace readiness guide lists what sellers report being asked for.
Decide whether a sports-only guard is a device in your market at all before you specify one.

Ask what the desk can supply for your file

Your message opens in WhatsApp with the page name added, so the desk knows what you are looking at.
Or write to sales@xinmeidaoralcare.com.

Notes

Not legal advice. Requirements vary by product, claims, market and supply-chain role. This guide is not legal advice; confirm the applicable route with your regulatory adviser before import and recheck it before sale.

Classification. The family summaries in the tables do not classify a catalogue reference.

Test reports. A test report is not assumed available for a catalogue reference: request it for the exact product and confirm availability, scope, holder, permission to share or rely on it, whether new testing is needed and any cost before relying on it.

Documents in your name. The desk does not hold a device clearance, a CE or UKCA file, a register entry, a cosmetic notification or a safety report in your name, and does not supply one with an order. Before ordering, agree which business holds each required document, which documents apply to your exact product, and which responsibilities remain with you.