Manufacturer registered with FDA

Seattle Bioceramics, Inc.

Kent, WA, United States. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10082812Manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1United States

Devices listed with FDA

What Seattle Bioceramics, Inc. 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
Purzir
2021

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

Also lists devices cleared under other names

Seattle Bioceramics, Inc. 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: 3DBiocad (1).

Decided510(k)DeviceApplicantDevice type
13 May 2020K193055Purzir Dental Zirconia3DBiocadEIH Porcelain Powder

Registered establishments

EstablishmentLocationWhat it does
SEATTLE BIOCERAMICS, INC.FDA reg. 3020611371Kent, WA, United StatesManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10082812). 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.