Pulpdent Corp.: FDA clearances and approvals
Pulpdent Corp. has 110 FDA 510(k) clearances (first 1990, latest 2021), across 21 product codes in 1 review panel. Median 510(k) review time: 77 days. Since 2017 its median was 171 days, against 126 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 7 | 85 |
| 2013 | 1 | 59 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 144 |
| 2017 | 0 | — |
| 2018 | 2 | 141 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 257 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Pulpdent Corp.'s cleared 510(k)s took a median 171 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 29 | 29 |
| EMA | Cement, Dental | 14 | 14 |
| KLE | Agent, Tooth Bonding, Resin | 11 | 11 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 10 | 10 |
| LBH | Varnish, Cavity | 10 | 10 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 9 | 9 |
| KIF | Resin, Root Canal Filling | 6 | 6 |
| EJK | Liner, Cavity, Calcium Hydroxide | 4 | 4 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 3 | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 2 | 2 |
Plus 11 more product codes.
Review panels
- Dental (110)
Most recent Pulpdent Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210045 | ACTIVA PRESTO PACK | EBF | 2021-09-22 | 257 |
| K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCP | DYH | 2018-01-17 | 111 |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCP | EBC | 2018-01-05 | 171 |
| K153249 | Pulpdent Solo Flowable Composite with MCP | EBF | 2016-04-01 | 144 |
| K130223 | RMGI FILL | EMA | 2013-03-29 | 59 |
| K123265 | RMGI LOW VISCOSITY | EMA | 2012-12-07 | 49 |
| K120784 | TUFF-TEMP 2.0 | EBG | 2012-06-08 | 85 |
| K120003 | NUCAL | EJK | 2012-04-05 | 93 |
| K120213 | ETCH-RITE SUPREME | KLE | 2012-03-30 | 66 |
| K113818 | EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL | EBC | 2012-03-21 | 85 |
100 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pulpdent Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Pulpdent Corp. have?
Pulpdent Corp. has 110 FDA 510(k) clearances (first 1990, latest 2021), across 21 product codes in 1 review panel.
How long does FDA take to clear Pulpdent Corp.'s 510(k)s?
The median time from FDA receipt to decision across Pulpdent Corp.'s cleared 510(k)s is 77 days. Since 2017: 171 days, versus 126 days for all cleared 510(k)s in the same product codes.
What devices does Pulpdent Corp. make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 29); EMA (Cement, Dental, 14); KLE (Agent, Tooth Bonding, Resin, 11).
Has Pulpdent Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pulpdent Corp. Related entities may recall under other names.
Next steps
- See all 110 Pulpdent Corp. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Pulpdent Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.