Dental Device Guide
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Not currently registered with FDA under this name

Kuraray Company, Ltd.

New York, NY, United States. Named as applicant on 35 dental 510(k) clearances between 1985 and 2000. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
351985–2000
Markets registered in
27 registrations outside the US
Establishments
0—
1985: 11986: 41987: 71988: 21989: 11990: 21991: 31993: 21994: 71995: 11997: 11998: 11999: 12000: 219801990200020102020

510(k) clearances per year, 1980–2026

Registered in 2 markets

Where regulators' registries name Kuraray Company, Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 35 clearancesSouth Korea: 7 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantKuraray Company, Ltd.35 clearances1985–2000Below
South KoreaMFDSManufacturerKURARAY CO., LTDKuraray Co., Ltd · Kuraray Co., Ltd. · +171998–2009Pure 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 Kuraray Company, Ltd. as the applicant.

Decided510(k)DeviceDevice type
10 Aug 2000K001914CLEARFIL REPAIRKLE Resin Tooth Bonding Agent
4 Aug 2000K001913CLEARFIL ST OPAQUEREBF Resin Tooth Shade Material
4 Feb 1999K990040CLEARFIL SE BONDKLE Resin Tooth Bonding Agent
24 Feb 1998K980232CLEARFIL DC CEMENTEMA Dental Cement
27 Mar 1997K965091TEETHMATE F-1EBC Pit and Fissure Sealant and Conditioner
11 Jul 1995K951813CARIES DETECTORLFC Caries Detection Device
10 Aug 1994K943170CLEARFIL LINER BOND 2KLE Resin Tooth Bonding Agent
10 Aug 1994K943169CLEARFIL AP-X AND LINER BOND 2EBF Resin Tooth Shade Material
10 Aug 1994K943168CLEARFIL AP-XEBF Resin Tooth Shade Material
10 Aug 1994K943167CLEARFIL NEW BONDKLE Resin Tooth Bonding Agent
10 Aug 1994K943166CLEARFIL LINER BOND SYSTEMKLE Resin Tooth Bonding Agent
10 Aug 1994K943165CLEARFIL PHOTO BONDKLE Resin Tooth Bonding Agent
24 Feb 1994K933030PANAVIA 21EMA Dental Cement
28 Jan 1993K925383PHOTO CLEARFIL OPAQUEREBF Resin Tooth Shade Material
11 Jan 1993K925404CLEARFIL PORCELAIN BOND ACTIVATORKLE Resin Tooth Bonding Agent
20 Aug 1991K912708CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEMEBF Resin Tooth Shade Material
20 Aug 1991K912707CLEARFIL LINER BOND SYSTEMKLE Resin Tooth Bonding Agent
3 Apr 1991K910424TEETHMATE-FEMA Dental Cement
13 Apr 1990K900690CLEARFIL VENEER BOND KITEBF Resin Tooth Shade Material
14 Mar 1990K897027TEETHMATE-AEBC Pit and Fissure Sealant and Conditioner
31 Mar 1989K890123CLEARFIL CR INLAYEBF Resin Tooth Shade Material
13 Jun 1988K882006CLEARFIL PHOTO COREEBF Resin Tooth Shade Material
2 Mar 1988K872588CLEARFIL PHOTO POSTERIOREBF Resin Tooth Shade Material
20 Nov 1987K872959CLEARFIL PHOTO BONDKLE Resin Tooth Bonding Agent
12 Nov 1987K873886CLEARFIL PORCELAIN REPAIR SYSTEMEBF Resin Tooth Shade Material
11 Aug 1987K872960CLEARFIL POSTERIOR NEW BONDEBF Resin Tooth Shade Material
17 Jul 1987K871637CLEARFIL CORE NEW BONDEBF Resin Tooth Shade Material
17 Jul 1987K871634CLEARFIL FII NEW BONDEBF Resin Tooth Shade Material
16 Jul 1987K871635CLEARFIL POSTERIOR 3EBF Resin Tooth Shade Material
2 Jul 1987K871636CLEARFIL PORCELAIN BONDKLE Resin Tooth Bonding Agent
5 Sep 1986K862942PHOTO CLEARFIL BRIGHTEBF Resin Tooth Shade Material
29 Jul 1986K862232PANAVIA TC, AND PANAVIA OPAQUEEBF Resin Tooth Shade Material
17 Apr 1986K860708PHOTO CLEARFIL OPAQUEREBF Resin Tooth Shade Material
13 Mar 1986K855211PANAVIA EX, A DENTAL ADHESIVEEMA Dental Cement
8 Apr 1985K850824PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL RESTEBF Resin Tooth Shade Material

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.