Bisco, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
88
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250156Choice 2 DCJuly 11, 2025
K242816QuantiumDecember 17, 2024
K192007TheraBase, TheraBase CaMarch 17, 2020
K182917FluoroCalNovember 18, 2019
K180344TheraCal DCApril 5, 2018
K171147REVEAL BulkAugust 4, 2017
K162598HAPI SealMay 23, 2017
K163171CeraCleanApril 14, 2017
K161051All-Bond Universal w/BAC (not finalized)September 9, 2016
K161256TheraCemJuly 29, 2016
K143292TheraCal DCAugust 4, 2015
K141439ORTHODONTIC ACRYLIC (NOT FINALIZED)September 12, 2014
K131734ALL-BOND UNIVERSAL SC (NOT FINALIZED)April 11, 2014
K123653SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)June 3, 2013
K113401ORTHO-1(NOT FINALIZED)February 7, 2012
K112118DREAMBONDNovember 17, 2011
K103514PRO-V COATMay 25, 2011
K102844ALL-BOUND 3October 29, 2010
K101787DUOLINK IIOctober 8, 2010
K101485ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCHAugust 26, 2010