Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bisco, Inc. — Predicate Candidate Screening
88 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
176 days90th percentile
88clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250156 | Choice 2 DC | Bisco, Inc. | 2025-07-11 | 171 | 0 |
| K242816 | Quantium | Bisco, Inc. | 2024-12-17 | 90 | 0 |
| K192007 | TheraBase, TheraBase Ca | Bisco, Inc. | 2020-03-17 | 232 | 0 |
| K182917 | FluoroCal | Bisco, Inc. | 2019-11-18 | 395 | 0 |
| K180344 | TheraCal DC | Bisco, Inc. | 2018-04-05 | 56 | 0 |
| K171147 | REVEAL Bulk | Bisco, Inc. | 2017-08-04 | 107 | 0 |
| K162598 | HAPI Seal | Bisco, Inc. | 2017-05-23 | 246 | 0 |
| K163171 | CeraClean | Bisco, Inc. | 2017-04-14 | 151 | 0 |
| K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | 2016-09-09 | 148 | 0 |
| K161256 | TheraCem | Bisco, Inc. | 2016-07-29 | 86 | 0 |
| K143292 | TheraCal DC | Bisco, Inc. | 2015-08-04 | 260 | 0 |
| K141439 | ORTHODONTIC ACRYLIC (NOT FINALIZED) | Bisco, Inc. | 2014-09-12 | 102 | 0 |
| K131734 | ALL-BOND UNIVERSAL SC (NOT FINALIZED) | Bisco, Inc. | 2014-04-11 | 302 | 0 |
| K123653 | SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZE | Bisco, Inc. | 2013-06-03 | 188 | 0 |
| K113401 | ORTHO-1(NOT FINALIZED) | Bisco, Inc. | 2012-02-07 | 82 | 0 |
| K112118 | DREAMBOND | Bisco, Inc. | 2011-11-17 | 115 | 0 |
| K103514 | PRO-V COAT | Bisco, Inc. | 2011-05-25 | 176 | 0 |
| K102844 | ALL-BOUND 3 | Bisco, Inc. | 2010-10-29 | 30 | 0 |
| K101787 | DUOLINK II | Bisco, Inc. | 2010-10-08 | 105 | 0 |
| K101485 | ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; | Bisco, Inc. | 2010-08-26 | 90 | 0 |
| K093470 | CORE-FLO D/C | Bisco, Inc. | 2010-02-17 | 103 | 0 |
| K091705 | PRIMER PLUS | Bisco, Inc. | 2009-08-28 | 79 | 0 |
| K082449 | BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45 | Bisco, Inc. | 2008-09-25 | 31 | 0 |
| K073263 | PRO-V | Bisco, Inc. | 2008-02-14 | 86 | 0 |
| K063780 | ACE BOND SE | Bisco, Inc. | 2007-01-19 | 29 | 0 |
| K063237 | THERACAL LC | Bisco, Inc. | 2006-12-08 | 43 | 0 |
| K060701 | BISCEM TRANSLUCENT, BISCEM OPAQUE | Bisco, Inc. | 2006-05-15 | 60 | 2 |
| K052122 | BISCO LED | Bisco, Inc. | 2006-03-29 | 236 | 0 |
| K051999 | BISCOVER LED | Bisco, Inc. | 2005-08-22 | 28 | 0 |
| K050647 | ALL-IN-ONE | Bisco, Inc. | 2005-04-20 | 37 | 0 |
| K043168 | BISCOVER LV | Bisco, Inc. | 2005-02-01 | 77 | 0 |
| K042804 | TESCERA OPAQUER POWDER/SCULPTING RESIN | Bisco, Inc. | 2005-02-01 | 112 | 0 |
| K034024 | TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS | Bisco, Inc. | 2004-03-19 | 81 | 0 |
| K033521 | BISBLOCK | Bisco, Inc. | 2004-01-16 | 70 | 0 |
| K033585 | DIAPEX | Bisco, Inc. | 2004-01-16 | 64 | 0 |
| K033472 | TESCERA U-BAR AND BARRELS | Bisco, Inc. | 2004-01-15 | 73 | 0 |
| K032597 | BISCEM GI | Bisco, Inc. | 2003-11-04 | 74 | 0 |
| K030951 | TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T | Bisco, Inc. | 2003-06-06 | 72 | 0 |
| K030585 | SCULPTING RESIN | Bisco, Inc. | 2003-04-28 | 63 | 0 |
| K030354 | BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCO | Bisco, Inc. | 2003-02-19 | 16 | 0 |
| K024046 | TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93 | Bisco, Inc. | 2003-02-06 | 62 | 0 |
| K021503 | UNINHIBITED | Bisco, Inc. | 2002-08-01 | 84 | 0 |
| K013519 | SIMPLE | Bisco, Inc. | 2002-01-17 | 86 | 0 |
| K012032 | FIRST SPEP | Bisco, Inc. | 2001-09-17 | 80 | 0 |
| K012180 | A-WEAR | Bisco, Inc. | 2001-09-05 | 55 | 0 |
| K011159 | ONE-STEP PLUS | Bisco, Inc. | 2001-06-08 | 58 | 0 |
| K010196 | TOTAL CURE | Bisco, Inc. | 2001-04-05 | 73 | 0 |
| K003361 | RENEW LS-2 | Bisco, Inc. | 2000-11-28 | 32 | 0 |
| K003317 | RENEW LS-1 | Bisco, Inc. | 2000-11-21 | 28 | 0 |
| K000426 | VIP- VARIABLE INTENSITY POLYMERIZER | Bisco, Inc. | 2000-04-12 | 63 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda