Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EJK — Predicate Candidate Screening
78 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
163 days90th percentile
78clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261728 | One-Fil LC | Mediclus Co., Ltd. | 2026-07-21 | 56 | 0 |
| K253248 | Bright Cavity Liner | Dmp Dental Industry S.A. | 2026-01-13 | 106 | 0 |
| K230270 | 3M™ VitCal Liner/Base | 3M Espe Dental Products | 2023-02-06 | 6 | 0 |
| K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, | Prevest Denpro Limited | 2022-05-13 | 280 | 0 |
| K201799 | CleaniCal | Maruchi | 2021-02-12 | 227 | 0 |
| K202413 | LC ResinCal PC | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | 2020-11-20 | 88 | 0 |
| K191103 | Parkell Desensitizer Gel | Parkell, Inc. | 2019-11-22 | 211 | 0 |
| K180344 | TheraCal DC | Bisco, Inc. | 2018-04-05 | 56 | 0 |
| K143292 | TheraCal DC | Bisco, Inc. | 2015-08-04 | 260 | 0 |
| K150559 | Life Fast Set, Life Regular Set | Sybron Dental Specialties | 2015-06-19 | 105 | 0 |
| K141047 | LC CALCIUMHYDROXIDE LINER | S&C Polymer Silicon- Und Composite Spezialitaeten | 2015-04-14 | 356 | 0 |
| K134022 | BASE IT | Spident Co., Ltd. | 2014-06-11 | 163 | 0 |
| K131068 | TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; T | Kuraray Noritake Dental, Inc. | 2013-08-27 | 132 | 0 |
| K122421 | TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEET | Kuraray Noritake Dental, Inc. | 2012-12-11 | 124 | 0 |
| K120003 | NUCAL | Pulpdent Corporation | 2012-04-05 | 93 | 0 |
| K113711 | LIME-LITE II | Pulpdent Corporation | 2012-03-05 | 77 | 0 |
| K111668 | CAVIOS CAVITY LINER | Neodental Chemical Products Co., Ltd. | 2011-08-19 | 66 | 0 |
| K063237 | THERACAL LC | Bisco, Inc. | 2006-12-08 | 43 | 0 |
| K060365 | APEXCAL | Ivoclar Vivadent, Inc. | 2006-04-17 | 63 | 0 |
| K033521 | BISBLOCK | Bisco, Inc. | 2004-01-16 | 70 | 0 |
| K022025 | MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEM | Milton Hodosh, M.D. | 2002-08-15 | 56 | 0 |
| K021146 | D/SENSE 1-STEP | Centrix, Inc. | 2002-07-02 | 84 | 0 |
| K012717 | LIFE 2 | Sybron Dental Specialties, Inc. | 2001-10-25 | 71 | 0 |
| K010176 | CALEX CONDITIONER | Stephen M Koral, Dmd | 2001-03-27 | 68 | 0 |
| K001050 | CALCIJECT | Centrix, Inc. | 2000-07-21 | 112 | 0 |
| K983477 | SUPER SEAL | Phoenix Dental, Inc. | 1998-12-22 | 81 | 0 |
| K973539 | ROEKO CALCIUM HYDROXIDE POINTS | Roeko USA, Inc. | 1997-10-30 | 42 | 0 |
| K970113 | ULTRA-BLEND PLUS | Ultradent Products, Inc. | 1997-04-02 | 79 | 0 |
| K970114 | ULTRACAL XS | Ultradent Products, Inc. | 1997-03-14 | 60 | 0 |
| K964191 | CALCIUM HYDROXIDE MEDICAMENT | Sybron Dental Specialties, Inc. | 1997-01-22 | 93 | 0 |
| K961708 | LIFE AND LIFE FAST SET | Sybron Dental Specialties, Inc. | 1996-05-30 | 28 | 0 |
| K953524 | ULTRA-BLEND | Ultradent Products, Inc. | 1995-08-24 | 28 | 0 |
| K953079 | LIMELIGHT | Pulpdent Corp. | 1995-08-07 | 35 | 0 |
| K944945 | PULPDENT CALCIUM HYDROXIDE PREPARATIONS | Pulpdent Corp. | 1994-11-30 | 54 | 0 |
| K944416 | LIFE | Sybron Dental Specialties, Inc. | 1994-11-29 | 78 | 0 |
| K943372 | CALCIUM HYDROXIDE PASTE | Ultradent Products, Inc. | 1994-09-19 | 68 | 0 |
| K941532 | BIOCALEX 6/9 | Bio-Probe, Inc. | 1994-08-02 | 125 | 0 |
| K933507 | NEEDLETUBE SYRINGE CARTRTIDGE | Centrix, Inc. | 1994-01-18 | 187 | 0 |
| K933999 | STERIBASE (ACCUBASE) | Centrix, Inc. | 1994-01-05 | 141 | 0 |
| K931502 | VIVAGLASS LINER | Ivoclar North America, Inc. | 1993-07-22 | 119 | 0 |
| K926419 | CALCICUR | Voco GmbH | 1993-03-31 | 98 | 0 |
| K921408 | LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE | Ultradent Products, Inc. | 1992-11-24 | 245 | 0 |
| K924182 | CALCIMOL LC | Voco GmbH | 1992-10-16 | 58 | 0 |
| K923849 | CALCIMOL | Voco GmbH | 1992-09-28 | 59 | 0 |
| K922721 | VLC DYCAL II | Dentsply Intl. | 1992-07-23 | 48 | 0 |
| K920692 | SEPTOCALCINE ULTRA | Specialites Septodont | 1992-04-21 | 67 | 0 |
| K913574 | SEPTOCAL CAVITY LINER | Specialites Septodont | 1991-09-30 | 49 | 0 |
| K912495 | IONOSEAL | Voco GmbH | 1991-07-30 | 55 | 0 |
| K911244 | VLC GLASS IONOMER LINER | Dentsply Intl. | 1991-06-28 | 99 | 0 |
| K905723 | IONOSEAL | Micro-Vac, Inc. | 1991-03-15 | 85 | 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