Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kuraray Noritake Dental, Inc. · Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
132 daysmedian FDA review time
238 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250673 | CERABIEN MiLai | Kuraray Noritake Dental, Inc. | 2025-05-29 | 84 | 0 |
| K233285 | KATANA Zirconia ONE For IMPLANT | Kuraray Noritake Dental, Inc. | 2024-05-24 | 238 | 0 |
| K231039 | CLEARFIL Universal Bond Quick 2 | Kuraray Noritake Dental, Inc. | 2023-12-13 | 245 | 0 |
| K220369 | Esthetic Colorant | Kuraray Noritake Dental, Inc. | 2022-09-23 | 227 | 0 |
| K213147 | CERABIEN MiLai | Kuraray Noritake Dental, Inc. | 2022-03-28 | 182 | 0 |
| K210504 | PANAVIA Veneer LC | Kuraray Noritake Dental, Inc. | 2021-06-11 | 109 | 0 |
| K193060 | Noritake Super Porcelain EX-3 | Kuraray Noritake Dental, Inc. | 2020-01-30 | 90 | 0 |
| K191980 | CLEARFIL MAJESTY ES Flow | Kuraray Noritake Dental, Inc. | 2019-11-18 | 117 | 0 |
| K191133 | KATANA Cleaner, KATANA Cleaner (Trial) | Kuraray Noritake Dental, Inc. | 2019-10-08 | 162 | 0 |
| K190436 | KATANA Zirconia Block | Kuraray Noritake Dental, Inc. | 2019-05-23 | 90 | 0 |
| K182430 | CLEARFIL MAJESTY IC | Kuraray Noritake Dental, Inc. | 2019-05-03 | 239 | 0 |
| K183537 | PANAVIA SA Cement Universal | Kuraray Noritake Dental, Inc. | 2019-04-25 | 127 | 0 |
| K170834 | CERABIEN ZR | Kuraray Noritake Dental, Inc. | 2017-10-17 | 211 | 0 |
| K170986 | KATANA Zirconia Block | Kuraray Noritake Dental, Inc. | 2017-07-13 | 101 | 0 |
| K161042 | CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL | Kuraray Noritake Dental, Inc. | 2016-10-25 | 195 | 0 |
| K153476 | KATANA AVENCIA Block | Kuraray Noritake Dental, Inc. | 2016-08-23 | 265 | 0 |
| K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Cle | Kuraray Noritake Dental, Inc. | 2015-08-21 | 156 | 0 |
| K150703 | CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS ( | Kuraray Noritake Dental, Inc. | 2015-08-13 | 148 | 0 |
| K143439 | KATANA Zirconia | Kuraray Noritake Dental, Inc. | 2015-02-27 | 87 | 0 |
| K142623 | PANAVIA SA Cement Plus Handmix | Kuraray Noritake Dental, Inc. | 2015-02-26 | 163 | 0 |
| K142625 | PANAVIA SA Cement Plus Automix; (Universal(A2), White, Trans | Kuraray Noritake Dental, Inc. | 2015-01-27 | 133 | 0 |
| K133211 | ZIRTOUGH | Kuraray Noritake Dental, Inc. | 2014-03-20 | 153 | 0 |
| K133078 | K-ETCHANT SYRINGE; NEEDLE TIP (E) | Kuraray Noritake Dental, Inc. | 2013-12-20 | 84 | 0 |
| K132450 | CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND | Kuraray Noritake Dental, Inc. | 2013-11-01 | 87 | 0 |
| K131534 | KATANA ZIRCONIA | Kuraray Noritake Dental, Inc. | 2013-10-11 | 135 | 0 |
| K131430 | CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL | Kuraray Noritake Dental, Inc. | 2013-08-30 | 105 | 0 |
| K131068 | TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; T | Kuraray Noritake Dental, Inc. | 2013-08-27 | 132 | 0 |
| K131432 | CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEAR | Kuraray Noritake Dental, Inc. | 2013-08-22 | 97 | 0 |
| K130371 | CLEARFIL MAJESTY ES FLOW | Kuraray Noritake Dental, Inc. | 2013-04-09 | 54 | 0 |
| K122421 | TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEET | Kuraray Noritake Dental, Inc. | 2012-12-11 | 124 | 0 |
| K121980 | ZIRPRIME | Kuraray Noritake Dental, Inc. | 2012-10-19 | 105 | 0 |
| K121583 | CLEARFIL MAJESTY FLOW | Kuraray Noritake Dental, Inc. | 2012-07-25 | 56 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda