Liner, Cavity, Calcium Hydroxide
Dental · 21 CFR 872.3250
Recent MDR events
14 adverse event reports on file
- DYCALJan 5, 2022InjuryDentsply Caulk2515379-2021-00020
- ULTRACAL XSMay 19, 2020InjuryUltradent Products, Inc1718912-2019-00002
- DYCAL RADIOPAQUE CALCIUM HYDROXIDE COMPOSITIONOct 17, 2019InjuryDentsply Caulk2515379-2019-00030
- ULTRADENT ULTRACAL XS CALCIUM HYDROXIDE PASTEOct 17, 2019InjuryUltradent Products, Inc. / Oratech LlcMW5090472
- LIFE REGULAR SETSep 27, 2018InjuryKerr Italia S.r.l.8020994-2018-00001
- ULTRACAL XSJan 15, 2018InjuryUltradent Products Inc1718912-2017-00041
- ULTRACAL XSDec 21, 2017InjuryUltradent Products, Inc.1718912-2017-00043
- SCOTCHBOND UNIVERSAL ETCHANTApr 4, 20133m Deutschland Gmbh9611385-2013-00006
- WHITENING GELOct 3, 2012OtherUltradent Products, Inc.1718912-2012-00005
- RETRACTION ALL TYPESOct 3, 2012OtherUltradent Products, Inc.1718912-2012-00004
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
84 firms currently registered for this product code
Oketz Logistics Llc
Coral Gables, FL, US
Solventum Germany Gmbh
Kamen North Rhine-Westphalia, DE
Solventum Germany Gmbh
SEEFELD Bavaria, DE
Kash Sales Inc.
Richmond Hill Ontario, CA
Neo Dental Chemical Products Co., Ltd.
NAGANO, JP
Mediclus Co., Ltd
Cheongju-si Chungbuk, KR
Parkell, Inc.
EDGEWOOD, NY, US
Mainline Medical Dental Supply
North York Ontario, CA
Scientific Pharmaceuticals, Inc.
POMONA, CA, US
Voco Gmbh
CUXHAVEN Lower Saxony, DE
Pulpdent Corporation
Watertown, MA, US
Kuraray Noritake Dental Niigata Plant
TAINAI Niigata, JP
Dmp Dental Industry S.a.
Markopoulo Attiki, GR
George Taub Products & Fusion Co., Inc.
JERSEY CITY, NJ, US
Essential Dental Systems, Inc.
S Hackensack, NJ, US
Solventum Us Llc
Eagan, MN, US
S & C Polymer Gmbh
ELMSHORN Schleswig-Holstein, DE
Identa Dental Material Gmbh
CUXHAVEN Lower Saxony, DE
Bisco, Inc.
Schaumburg, IL, US
Soher Med Limited
Hong Kong, HK
510(k) clearances
78 clearances for this product code
- Mediclus Co., Ltd.Jul 21, 2026
K261728 · One-Fil LC
- Dmp Dental Industry S.A.Jan 13, 2026
K253248 · Bright Cavity Liner
- 3M Espe Dental ProductsFeb 6, 2023
K230270 · 3M VitCal Liner/Base
- Prevest Denpro LimitedMay 13, 2022
K212475 · Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
- MaruchiFeb 12, 2021
K201799 · CleaniCal
- S&C Polymer Silicon- Und Composite Spezialitaten GmbHNov 20, 2020
K202413 · LC ResinCal PC
- Parkell, Inc.Nov 22, 2019
K191103 · Parkell Desensitizer Gel
- Bisco, Inc.Apr 5, 2018
K180344 · TheraCal DC