SEPTODONT

Listed in a source registry

US FDA device registration and listing (open.fda.gov)

What is established and what is not

No researcher review has been written for this company yet. 6 official records from 6 official sources are on file. 2 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.

Facts on file, each with its evidence type

• Site address listed in a government regulator's register (record type: facility-registered; this record does not by itself establish manufacturing) [official record; status green] Shows the regulator records a site of this company at a named address. A registration is not an observation of current production. effective since 2026-08-17. US FDA device establishment registration (openFDA)
• product-authorised-for-sale (record type: product-authorised-for-sale; this record does not by itself establish manufacturing) [official record; status green] A national regulator lists this company as the MAKER of products it has authorised for sale in that country. It is an export footprint you can check, not a quality rating: the register says the goods were allowed in, not that they are good. checked 2026-08-21. Ministry of Health of Armenia, State Register of Medicinal Products (pharm.am)
• Places goods on the market (national producer register) (record type: places-goods-on-market; this record does not by itself establish manufacturing) [official record; status green] A state register lists this company as placing these goods on the market, as their maker or importer. By itself it does not show who makes them. checked 2026-08-07. Finnish Medicines Agency (Fimea), basic register of medicinal products
• Market access approved: European Union (record type: market-access-eu) [official record; status green] Shows the establishment is approved for the listed activities under the EU food-hygiene rules and appears in the EU list of approved establishments. It is not an import check and not an observation of current production. checked 2026-08-22. TRACES NT, European Commission register of approved establishments (DG SANTE)
• No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-20. OpenSanctions
• No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-20. OpenSanctions
• product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 2 medical devices: BioRoot Flow 0.5g, BioRoot Flow 2g (K212283, 2021-09-16), Biodentine XP 500, Biodentine XP 200 (K211799, 2021-08-10). The applicant answers for the notification; the record does not say who makes the device. A national regulator lists this company as the holder of the registration of products it has authorised for sale in that country. The holder answers for the product on that market; the record does not say the holder makes it. effective since 2026-10-05. FDA premarket notifications 510(k) and De Novo (openFDA, U.S. Food and Drug Administration)
• Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-17. ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers

Relationships

2 relationship(s) on file. Each line names the other party, the relationship as its source records it, and the source. A record of a relationship is not a finding about control beyond what it literally says.

Candidates, not confirmed

• 9610964: Site named in the record, registry number 9610964. US FDA device establishment registration (openFDA)
• 58 RUE DU PONT DE CRETEIL, 94100, Saint-Maur-des-Fossés: Holds the site's permit, registry number FR94068046. TRACES NT, European Commission register of approved establishments (DG SANTE)

Import rules for these goods

• Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
• For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)

Check independently

• Sanctions and watchlists (OpenSanctions)