510(k) Report

FDA applicant

Bisco, Inc.

Schaumburg, IL88 decisions1984–20252 recalls

FDA records 88 decisions for Bisco, Inc. (Schaumburg, IL) from 1984 to 2025: 88 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and KLE (Agent, Tooth Bonding, Resin). Since 2016 its 510(k)s took a median of 128 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 49 predicates, 23 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Bisco, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 12008: 22009: 12010: 42011: 22012: 12013: 12014: 22015: 12016: 22017: 32018: 12019: 12020: 12024: 12025: 1
2007high 4 (2010) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

2in 2008

2008: 2
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Bisco, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bisco, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EBFMaterial, Tooth Shade, Resin30decisions
  • KLEAgent, Tooth Bonding, Resin18decisions
  • EMACement, Dental9decisions
  • EBDCoating, Filling Material, Resin6decisions
  • EJKLiner, Cavity, Calcium Hydroxide4decisions
  • DYHAdhesive, Bracket And Tooth Conditioner, Resin4decisions

Also: EBI (3), EBC (3), EBG (2), LBH (2), EBZ (2), ELR (1).

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 128 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 134 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 49 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 81 times; 23 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K910860All-Bond 2Bisco, Inc. · 19917cite it
  • K955292AelitefloBisco, Inc. · 19954cite it
  • K063237Theracal LCBisco, Inc. · 20064cite it
  • K924151Bisco D/C ResinomerBisco, Inc. · 19924cite it
  • K945604EcliptomerBisco, Inc. · 19954cite it
  • K915668Bisco Cavity CleanserBisco, Inc. · 19924cite it

What has FDA decided for it lately?

  • K250156Choice 2 DCBisco, Inc. · 2025
  • K242816QuantiumBisco, Inc. · 2024
  • K192007TheraBase, TheraBase CaBisco, Inc. · 2020
  • K182917FluoroCalBisco, Inc. · 2019
  • K180344TheraCal DCBisco, Inc. · 2018
  • K171147REVEAL BulkBisco, Inc. · 2017
  • K162598HAPI SealBisco, Inc. · 2017
  • K163171CeraCleanBisco, Inc. · 2017

All 88 as Bisco, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K060701Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Translucent; The…Apr 28, 2008
  • K060701Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Opaque; The product is…Apr 28, 2008