Kulzer, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
38
Inspections
7
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260783Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneMarch 11, 2026
K254063iCEM Universal PlusDecember 19, 2025
K243910RetraxilSeptember 24, 2025
K240660Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; SSeptember 17, 2024
K233868dima Print Teeth & TempMay 23, 2024
K230644Signum opaque FSeptember 7, 2023
K220605Venus Bulk Flow ONEApril 21, 2022
K905058PALAVIT LJune 6, 1991
K904928PALAVIT GLCJune 6, 1991
K910263CHARISMAJune 3, 1991
K910719SILICOATER MDApril 29, 1991
K905131DURAFILL COLOR VSMarch 15, 1991
K905302DENTHESIVEFebruary 26, 1991
K904555DURAFILL FLOWNovember 13, 1990
K903317DENTALON PLUSAugust 13, 1990
K902115PALAPRESS(R) VARIO RESINJuly 27, 1990
K902350PALATRAY LC RESIN IMPRESSION TRAY MATERIALJuly 26, 1990
K901789PALADON(R) 65June 22, 1990
K901681FORMASIL(R)A POLYVINYL SILOXANE LINEJune 15, 1990
K901697SILISTOR CERAMIC AND RESIN REPAIR SYSTEMJune 15, 1990