Quick answer: there is no single European authorisation that automatically allows anyone to apply tooth gems in every country. National rules on activities and professions, the legislation applicable to each product, safety and information duties, insurance and local business requirements must be checked separately.
A product being freely sold, a private training certificate or the presence of a CE logo does not, on its own, establish that every use or provider is authorised.
The four levels to check
- The activity and the person: does the country reserve particular interventions on teeth to a regulated profession?
- The product: what is its intended purpose and which rules apply?
- Placing it on the market: have the manufacturer, importer or distributor supplied the required information and documents?
- The service: do hygiene, client information, insurance, rules for minors, advertising and incident handling meet local requirements?
These checks complement one another. A compliant product does not automatically grant a right to perform an activity, and a professional qualification does not replace product verification.
1. Practice rules remain national
Regulated professions and their scope vary between European countries. The official Your Europe portal recommends checking the regulated-professions database and contacting the assistance centre or competent authority in the country concerned.
Dentistry is a regulated profession, but a general description of the profession does not decide every commercial situation involving tooth gems. The legal classification of a specific act needs to be confirmed with a competent authority or suitably qualified local legal adviser.
Before offering a service, document the country, the provider’s status, the exact actions being considered and the insurer’s position. The provider guide lists practical questions to ask.
2. Intended purpose determines the product framework
Regulation (EU) 2017/745 defines intended purpose by reference to information supplied by the manufacturer, including the label, instructions for use and promotional or sales materials. A product should not be reclassified solely from its appearance or from the way a reseller would like to use it.
If a product falls under the Medical Device Regulation, its requirements apply. If it does not, other rules may apply, including the General Product Safety Regulation and, for certain substances or mixtures, REACH and CLP.
CE marking is not universal
CE marking is mandatory only for categories covered by EU legislation that requires it. Its absence is therefore not automatically non-compliance; conversely, a logo or voluntary certificate does not prove conformity where a specific regulatory regime applies. The legislation, manufacturer, declaration and intended purpose all need to be identified.
3. General safety, traceability and information
Regulation (EU) 2023/988 on general product safety has applied since 13 December 2024 to products within its scope. It includes requirements concerning risk analysis, appropriate technical documentation, product identification, relevant operator contact details and, where needed, instructions and safety information that users can understand.
For a chemical product or mixture, labels and safety data sheets need to be examined where required. The official Your Europe portal explains that CLP classification communicates hazards through the relevant pictograms, statements and precautionary advice.
A very short product page or a claim of “extreme hold” does not replace a clear intended purpose, traceability or instructions.
Documents to request and retain
- exact product name and reference;
- manufacturer identity and contact details and, where applicable, the EU importer or responsible operator;
- batch, serial number or another traceability identifier;
- intended purpose, intended users and applicable instructions;
- date, shelf life and storage conditions where provided;
- warnings, contraindications and manufacturer-stated actions in case of a problem;
- EU declaration of conformity and CE marking only where required by applicable legislation;
- CLP labelling and a safety data sheet where required;
- proof of purchase and a history of batches used;
- a process for reporting, withdrawing or recalling a product.
The aim is not to collect logos. It is to connect a product and batch to a verifiable purpose and set of safety information.
Before offering a service
- Check the authorised scope of activity in the country and region.
- Obtain written confirmation from the insurer for the activity actually offered.
- Define when to postpone and refer someone to a dentist.
- Establish a hygiene process appropriate to contact with the mouth and saliva.
- Prepare fair information about risks, limitations, aftercare and removal.
- Check local rules for minors and consent.
- Retain references and batches for products used.
- Plan how complaints, incidents or product recalls will be managed.
CDC guidance applies to dental health-care settings and is not European law, but it illustrates standard precaution principles: hand hygiene, appropriate protection, correctly processed equipment and cleaned or disinfected surfaces. Also read the hygiene and safety guide.
Four misconceptions to avoid
“A private course provides legal authorisation”
No. Training can provide knowledge, but it does not replace a regulated qualification, professional registration or authorisation where one is required.
“It is sold online, so every use is allowed”
No. Commercial availability does not define the manufacturer’s intended purpose or the right to carry out an activity in a country.
“Every product must have CE marking”
No. CE marking applies only to categories covered by legislation that requires it.
“The rules are identical throughout Europe”
No. Some product regulations are European, but professions, permitted activities, insurance and formalities remain largely national or local.
How to check your country
- Use the European regulated-professions database.
- Identify the national authority responsible for health or the dental profession.
- Ask the relevant local body about the exact act rather than using a vague description.
- Request confirmation from the insurer and, when necessary, a local legal adviser.
- Keep dated answers and schedule regular reviews.
This method is more reliable than a static country list because legislation and its interpretation can change.
Related guides
Official sources and limitations
- EUR-Lex: Regulation (EU) 2023/988 on general product safety
- EUR-Lex: Regulation (EU) 2017/745 on medical devices
- Your Europe: regulated professions
- Your Europe: general product compliance
- Your Europe: classification, labelling and packaging of chemicals
- CDC: standard precautions in dental settings
Sources checked on 4 September 2026. This page provides a general orientation method, not legal, regulatory or medical advice. Have your country, products, intended acts and situation confirmed by the relevant authorities and professionals.




Leave a comment
This site is protected by hCaptcha and the hCaptcha Privacy Policy and Terms of Service apply.