Bisco, Inc.: FDA filings under this applicant name
FDA lists 88 510(k) clearances under the applicant name “Bisco, Inc.” (first 1984, latest 2025), across 16 product codes in 1 review panel. Median 510(k) review time under this name: 72 days. Since 2017 the median was 161 days, against 120 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 82 |
| 2013 | 1 | 188 |
| 2014 | 2 | 202 |
| 2015 | 1 | 260 |
| 2016 | 2 | 117 |
| 2017 | 3 | 151 |
| 2018 | 1 | 56 |
| 2019 | 1 | 395 |
| 2020 | 1 | 232 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 90 |
| 2025 | 1 | 171 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bisco, Inc. took a median 161 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 30 | 30 |
| KLE | Agent, Tooth Bonding, Resin | 18 | 18 |
| EMA | Cement, Dental | 9 | 9 |
| EBD | Coating, Filling Material, Resin | 6 | 6 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 4 | 4 |
| EJK | Liner, Cavity, Calcium Hydroxide | 4 | 4 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 3 | 3 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 3 | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 2 | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 2 | 2 |
Plus 6 more product codes.
Review panels
- Dental (88)
Most recent Bisco, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250156 | Choice 2 DC | EMA | 2025-07-11 | 171 |
| K242816 | Quantium | EBF | 2024-12-17 | 90 |
| K192007 | TheraBase, TheraBase Ca | EMA | 2020-03-17 | 232 |
| K182917 | FluoroCal | LBH | 2019-11-18 | 395 |
| K180344 | TheraCal DC | EJK | 2018-04-05 | 56 |
| K171147 | REVEAL Bulk | EBF | 2017-08-04 | 107 |
| K162598 | HAPI Seal | EBC | 2017-05-23 | 246 |
| K163171 | CeraClean | PME | 2017-04-14 | 151 |
| K161051 | All-Bond Universal w/BAC (not finalized) | KLE | 2016-09-09 | 148 |
| K161256 | TheraCem | EMA | 2016-07-29 | 86 |
78 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-04-28.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bisco, Inc.?
FDA lists 88 510(k) clearances under the applicant name “Bisco, Inc.” (first 1984, latest 2025), across 16 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bisco, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bisco, Inc. is 72 days. Since 2017: 161 days, versus 120 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bisco, Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 30); KLE (Agent, Tooth Bonding, Resin, 18); EMA (Cement, Dental, 9).
Next steps
- See all 88 Bisco, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Bisco, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.