Pentron Corp.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Pentron Corp.” (first 1984, latest 2002), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 57 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 10 | 10 |
| KLE | Agent, Tooth Bonding, Resin | 2 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EIH | Powder, Porcelain | 1 | 1 |
Review panels
- Dental (15)
Most recent Pentron Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021457 | FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL | EBG | 2002-08-01 | 87 |
| K874189 | DUAL-CURE RADIOPAQUE | EBF | 1988-02-11 | 120 |
| K874275 | OPTEC SUPPLEMENTARY KIT | EBF | 1988-01-19 | 91 |
| K874162 | OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT | EBF | 1988-01-12 | 91 |
| K873683 | CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL) | EBF | 1987-11-16 | 63 |
| K873878 | #24L SYSTEM | EBF | 1987-10-27 | 35 |
| K864404 | PENTRON HIGH STRENGTH PORCELAIN | EIH | 1986-11-24 | 14 |
| K854803 | CHAMELEON BONDING KIT | EBF | 1986-03-04 | 92 |
| K844057 | C-22 PIT & FISSURE SEALANT | EBC | 1984-12-03 | 46 |
| K841458 | NUMBER 20 R/L SYSTEM | KLE | 1984-05-22 | 43 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pentron Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pentron Clinical Technologies (13 510(k)s)
- Pentron Laboratory Technologies (5 510(k)s)
- Pentron Clinical (4 510(k)s)
- Pentron Ceramics, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pentron Corp.?
FDA lists 15 510(k) clearances under the applicant name “Pentron Corp.” (first 1984, latest 2002), across 5 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 Pentron Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pentron Corp. is 57 days.
Which FDA product codes appear under Pentron Corp.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 10); KLE (Agent, Tooth Bonding, Resin, 2); EBC (Sealant, Pit And Fissure, And Conditioner, 1).
Next steps
- See all 15 Pentron Corp. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Pentron Corp.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.