Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

88 results for "Bisco, Inc."
1–24 of 88
Search insights Median review: 72d Cleared: 100% Top manufacturer: Bisco, Inc. Lead specialty: Dental
Cleared Jul 11, 2025
Choice 2 DC
K250156 · EMA
Bisco, Inc.
Dental · 171d
Cleared Dec 17, 2024
Quantium
K242816 · EBF
Bisco, Inc.
Dental · 90d
Cleared Mar 17, 2020
TheraBase, TheraBase Ca
K192007 · EMA
Bisco, Inc.
Dental · 232d
Cleared Nov 18, 2019
FluoroCal
K182917 · LBH
Bisco, Inc.
Dental · 395d
Cleared Apr 05, 2018
TheraCal DC
K180344 · EJK
Bisco, Inc.
Dental · 56d
Cleared Aug 04, 2017
REVEAL Bulk
K171147 · EBF
Bisco, Inc.
Dental · 107d
Cleared May 23, 2017
HAPI Seal
K162598 · EBC
Bisco, Inc.
Dental · 246d
Cleared Apr 14, 2017
CeraClean
K163171 · PME
Bisco, Inc.
Dental · 151d
Cleared Sep 09, 2016
All-Bond Universal w/BAC (not finalized)
K161051 · KLE
Bisco, Inc.
Dental · 148d
Cleared Jul 29, 2016
TheraCem
K161256 · EMA
Bisco, Inc.
Dental · 86d
Cleared Aug 04, 2015
TheraCal DC
K143292 · EJK
Bisco, Inc.
Dental · 260d
Cleared Sep 12, 2014
ORTHODONTIC ACRYLIC (NOT FINALIZED)
K141439 · EBI
Bisco, Inc.
Dental · 102d
Cleared Apr 11, 2014
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
K131734 · KLE
Bisco, Inc.
Dental · 302d
Cleared Jun 03, 2013
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
K123653 · LBH
Bisco, Inc.
Dental · 188d
Cleared Feb 07, 2012
ORTHO-1(NOT FINALIZED)
K113401 · DYH
Bisco, Inc.
Dental · 82d
Cleared Nov 17, 2011
DREAMBOND
K112118 · KLE
Bisco, Inc.
Dental · 115d
Cleared May 25, 2011
PRO-V COAT
K103514 · EBG
Bisco, Inc.
Dental · 176d
Cleared Oct 29, 2010
ALL-BOUND 3
K102844 · KLE
Bisco, Inc.
Dental · 30d
Cleared Oct 08, 2010
DUOLINK II
K101787 · EMA
Bisco, Inc.
Dental · 105d
Cleared Aug 26, 2010
ALL-ETCH, ALL- ETCH WITH BAC
K101485 · KLE
Bisco, Inc.
Dental · 90d
Cleared Feb 17, 2010
CORE-FLO D/C
K093470 · EBF
Bisco, Inc.
Dental · 103d
Cleared Aug 28, 2009
PRIMER PLUS
K091705 · KLE
Bisco, Inc.
Dental · 79d
Cleared Sep 25, 2008
BISCEM TRANSLUCENT, MODEL D-45011
K082449 · EMA
Bisco, Inc.
Dental · 31d
Cleared Feb 14, 2008
PRO-V
K073263 · EBG
Bisco, Inc.
Dental · 86d