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Kuraray Noritake Dental, Inc.

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories6
Latest FDA decision2025-05-29
TypeNumberDevice NameCodeDateActions
510(k) K250673 CERABIEN MiLaiEIH2025-05-29 View
510(k) K233285 KATANA Zirconia ONE For IMPLANTNHA2024-05-24 View
510(k) K231039 CLEARFIL Universal Bond Quick 2KLE2023-12-13 View
510(k) K220369 Esthetic ColorantEIH2022-09-23 View
510(k) K213147 CERABIEN MiLaiEIH2022-03-28 View
510(k) K210504 PANAVIA Veneer LCEMA2021-06-11 View
510(k) K193060 Noritake Super Porcelain EX-3EIH2020-01-30 View
510(k) K191980 CLEARFIL MAJESTY ES FlowEBF2019-11-18 View
510(k) K191133 KATANA Cleaner, KATANA Cleaner (Trial)PME2019-10-08 View
510(k) K190436 KATANA Zirconia BlockEIH2019-05-23 View
510(k) K182430 CLEARFIL MAJESTY ICEBF2019-05-03 View
510(k) K183537 PANAVIA SA Cement UniversalEMA2019-04-25 View
510(k) K170834 CERABIEN ZREIH2017-10-17 View
510(k) K170986 KATANA Zirconia BlockEIH2017-07-13 View
510(k) K161042 CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value packKLE2016-10-25 View
510(k) K153476 KATANA AVENCIA BlockEBF2016-08-23 View