FDA 510(k) Applications for Medical Device Product Code "EJK"
(Liner, Cavity, Calcium Hydroxide)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K230270 | 3M ESPE Dental Products | 3MÖ VitCal Liner/Base | 02/06/2023 |
| K143292 | Bisco Inc | TheraCal DC | 08/04/2015 |
| K033521 | BISCO, INC. | BISBLOCK | 01/16/2004 |
| K180344 | Bisco, Inc. | TheraCal DC | 04/05/2018 |
| K063237 | BISCO, INC. | THERACAL LC | 12/08/2006 |
| K001050 | CENTRIX, INC. | CALCIJECT | 07/21/2000 |
| K021146 | CENTRIX, INC. | D/SENSE 1-STEP | 07/02/2002 |
| K060365 | IVOCLAR VIVADENT, INC. | APEXCAL | 04/17/2006 |
| K131068 | KURARAY NORITAKE DENTAL INC. | TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID | 08/27/2013 |
| K122421 | KURARAY NORITAKE DENTAL INC. | TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID | 12/11/2012 |
| K201799 | Maruchi | CleaniCal | 02/12/2021 |
| K022025 | MILTON HODOSH, M.D. | MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT | 08/15/2002 |
| K111668 | NEO DENTAL CHEMICAL PRODUCTS CO., LTD. | CAVIOS CAVITY LINER | 08/19/2011 |
| K191103 | Parkell, Inc. | Parkell Desensitizer Gel | 11/22/2019 |
| K983477 | PHOENIX DENTAL, INC. | SUPER SEAL | 12/22/1998 |
| K212475 | Prevest Denpro Limited | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | 05/13/2022 |
| K113711 | PULPDENT CORPORATION | LIME-LITE II | 03/05/2012 |
| K120003 | PULPDENT CORPORATION | NUCAL | 04/05/2012 |
| K973539 | ROEKO USA, INC. | ROEKO CALCIUM HYDROXIDE POINTS | 10/30/1997 |
| K141047 | S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN | LC CALCIUMHYDROXIDE LINER | 04/14/2015 |
| K202413 | S&C Polymer Silicon- und Composite Spezialitaten GmbH | LC ResinCal PC | 11/20/2020 |
| K134022 | SPIDENT CO., LTD. | BASE IT | 06/11/2014 |
| K010176 | STEPHEN M. KORAL, D.M.D. | CALEX CONDITIONER | 03/27/2001 |
| K150559 | SYBRON DENTAL SPECIALTIES | Life Fast Set, Life Regular Set | 06/19/2015 |
| K964191 | SYBRON DENTAL SPECIALTIES, INC. | CALCIUM HYDROXIDE MEDICAMENT | 01/22/1997 |
| K012717 | SYBRON DENTAL SPECIALTIES, INC. | LIFE 2 | 10/25/2001 |
| K961708 | SYBRON DENTAL SPECIALTIES, INC. | LIFE AND LIFE FAST SET | 05/30/1996 |
| K970113 | ULTRADENT PRODUCTS, INC. | ULTRA-BLEND PLUS | 04/02/1997 |
| K970114 | ULTRADENT PRODUCTS, INC. | ULTRACAL XS | 03/14/1997 |
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