2027 legal guide
Requirements to open a dental lab.
Some countries require a licence before you make anything. In others, a notice is enough. Pick your country and see what they ask for.
Your country
Choose where you'll open.
United States
No federal licence. The states decide.
Seven verified states require registration or a permit to operate. South Carolina registers the technician.
- No federal licence.
No mandatory federal credential was found either.
- FDA.
In 2025 it denied the 807.65(i) exemption to a lab selling directly to patients.
- Foreign labs.
They must register with FDA and name a US agent.
Your first stepAsk your state dental board whether it requires registration and who must be in charge.
Unconfirmed. We did not review the law in 31 jurisdictions. If your state isn't listed, ask its dental board.
Spain
A licence from your region, not from AEMPS.
A lab is a manufacturer of custom-made devices and needs a licence before it makes anything.
- Prior operating licence.
Granted by the autonomous community.
- Registry of responsible persons.
Entry for custom-made devices.
- A protésico runs it.
A non-protésico can own it, but a qualified or authorized protésico must direct it.
- Annex XIII file.
Kept for 10 years; 15 for implantables.
- Professional college.
No national rule, but confirmed as mandatory in Madrid and Valencia.
Your first stepSecure your protésico before signing a lease, and ask your region for its requirements and fees.
Watch the deadline. Madrid decides in three months and silence means refusal. Euskadi takes six and silence means approval.
Mexico
The law points to a notice, not a licence.
No authority has said so for dental labs: this is a reading of the general rule.
- Operating notice.
COFEPRIS-05-006, Modality A, SCIAN 339111. Confirm the code before filing.
- Thirty days ahead.
Article 200 Bis of the General Health Law asks for that much notice.
- Responsable sanitario.
The form asks for one; the law is unclear.
- Registered diploma.
Article 79 requires it for technical work in dentistry and prosthetics.
- Land use and IMSS.
The local licence varies by municipality.
Your first stepSend COFEPRIS a written query on the registro sanitario and the responsable sanitario.
Unresolved. The law requires a registro sanitario for prostheses and has no exception for custom pieces. Only a written query to COFEPRIS will settle it.
Latin America
Every country, a different process.
It ranges from a prior certificate to a notice after you start.
Your first stepHire your technical director first: the employment is proven by the contract.
Not researched. Bolivia, Paraguay, Venezuela and much of Central America were left out. A rule not appearing here doesn't mean it doesn't exist.
Almost everywhere
What keeps repeating.
- A dentist's written order.
Without one, nothing gets made.
- No dealing with patients.
Selling direct is the fastest route to tougher rules.
- A qualified person in charge.
Spain, Colombia, Chile, Brazil and Argentina require one.
Questions
Straight answers.
It depends on the country. Spain, Colombia, Chile and Guatemala require authorization before you start. The USA has no federal licence and it depends on the state. Peru asks only for a notice after you start.
Often yes, but you need a qualified person in charge. In Spain a non-protésico can own a lab, but a qualified or authorized protésico must direct it. In Mendoza, Argentina, the holder must be a licensed prosthetics technician.
The autonomous community, not AEMPS. The lab must also enter the Registry of responsible persons for custom-made devices.
The text of the rule points to an operating notice, not a licence. No authority has confirmed this for dental labs, and whether finished prostheses need a registro sanitario remains unresolved.
US labs that only fill dentists' orders have relied on the 807.65(i) exemption. FDA denied it in 2025 to a lab selling directly to patients, and foreign labs must register.
Rarely without consequences. In most countries reviewed, the lab works on a dentist's written order and does not deal with patients.
Sources · United States
The rules, linked.
We mark any link that is a copy rather than the official publication.
- 21 CFR 807.65The registration exemption. Unofficial copy.
- FDA letter, 2025The case of the direct-to-patient lab.
- Florida 466.032Lab registration.
- Texas, chapter 266Lab registration. Unofficial copy.
- Oregon, HB 2594A law firm's summary, not the statute.
- Washington, RCW 70.352Lab registration. Unofficial copy.
Before you invest
Get the answers in writing.
The questions that matter most can be settled with a query to your local authority.