Manufacturer registered with FDA

estetic ceram ag

Triesen, Liechtenstein. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10044453Contract manufacturerManufacturer1 clearance in five years
Device types listed
1
Brands and models
3
510(k) clearances
12025–2025
Markets registered in
467 registrations outside the US
Establishments
1Liechtenstein
2025: 120102020

510(k) clearances per year, 2007–2026

Registered in 4 markets

Where regulators' registries name estetic ceram ag as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedCanada: 65 registrationsEuropean Union: 1 registrationsUnited Kingdom: 1 registrations
RegisteredHome: LiechtensteinOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerestetic ceram ag1 clearances2025–2025Below
CanadaHealth CanadaRegistration holderESTETIC CERAM AG652017–2021Pure Global AI
European UnionEUDAMEDManufacturerEstetic Ceram AG1—Pure Global AI
United KingdomMHRAManufacturerEstetic Ceram AG1—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What estetic ceram ag currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Porcelain PowderEIH · Class 2Dental ceramics & zirconiaMaker
iNK3DmµILLUSIONpriti perfect
2013

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names estetic ceram ag as the applicant.

Decided510(k)DeviceDevice type
5 Jun 2025K251084zirkon; structure; LFU shades, stains and glazesEIH Porcelain Powder

Also lists devices cleared under other names

estetic ceram ag lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Aesthetic-Press, LLC (1).

Decided510(k)DeviceApplicantDevice type
5 Jun 2017K163228APVolution SystemAesthetic-Press, LLCEIH Porcelain Powder

Registered establishments

EstablishmentLocationWhat it does
ESTETIC CERAM AGFDA reg. 3009081830Triesen, LiechtensteinContract manufacturer, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10044453). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.