Not currently registered with FDA under this name

Noritake Co., Inc.

Washington, DC, United States. Named as applicant on 14 dental 510(k) clearances between 1989 and 2011. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
141989–2011
Markets registered in
22 registrations outside the US
Establishments
0—
1989: 11998: 31999: 22003: 22005: 42011: 219801990200020102020

510(k) clearances per year, 1980–2026

Registered in 2 markets

Where regulators' registries name Noritake Co., Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 14 clearancesSouth Korea: 2 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantNoritake Co., Inc.14 clearances1989–2011Below
South KoreaMFDSManufacturerNORITAKE CO.,LTD.21998–1998Pure 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

510(k) clearances

Clearances on which FDA names Noritake Co., Inc. as the applicant.

Decided510(k)DeviceDevice type
12 Aug 2011K111383ZIRPRIMEEIH Porcelain Powder
30 Jun 2011K111107SUPER PORCELAIN EX-3 UNIVERSAL OPAQUEEIH Porcelain Powder
23 Nov 2005K052304SUPER PORCELAIN EX-3 PRESSEIH Porcelain Powder
11 May 2005K050920CZR PRESS LF STAINSEIH Porcelain Powder
7 Feb 2005K050160KATANA ZIRCONIAEIH Porcelain Powder
11 Jan 2005K043462CZR PRESS LFEIH Porcelain Powder
22 Dec 2003K031968CERABIEN ZREIH Porcelain Powder
24 Oct 2003K033049CZR PRESSEIH Porcelain Powder
3 Sep 1999K992023GRAND CERAMEIH Porcelain Powder
27 Aug 1999K992024SUPER PORCELAIN TI-22EIH Porcelain Powder
22 Dec 1998K983470SUPER PORCELAIN STAIN- PURE WHITEEIH Porcelain Powder
3 Nov 1998K983247SUPER PORCELAIN ADDMATEEIH Porcelain Powder
30 Oct 1998K982766PASTE OPAQUE EX-3EIH Porcelain Powder
10 Jan 1989K884356NORITAKE SUPER PORCELAIN EX-3EIH Porcelain Powder

Some of these clearances are listed with FDA today by another company: Kuraray Noritake Dental, Inc. (11).

Sources

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 of the most recent filing, which can be a US agent.