Pentron Clinical Technologies: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Pentron Clinical Technologies” (first 2002, latest 2009), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 71 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 | 3 | 3 |
| EMA | Cement, Dental | 3 | 3 |
| KIF | Resin, Root Canal Filling | 2 | 2 |
| KLE | Agent, Tooth Bonding, Resin | 2 | 2 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| EKM | Gutta-Percha | 1 | 1 |
Review panels
- Dental (13)
Most recent Pentron Clinical Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091512 | BUILD-IT LIGHT CURE | EBF | 2009-10-30 | 162 |
| K081887 | LUTE-IT II VENEER CEMENT, MODEL NO6 | EMA | 2008-08-29 | 58 |
| K072830 | RM BOND, MODEL J032 | DYH | 2007-12-04 | 62 |
| K072480 | GENERATION 8 SE ADHESIVE | KLE | 2007-11-21 | 78 |
| K072545 | ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 | EBF | 2007-10-26 | 46 |
| K071500 | NANO-BOND II ADHESIVE SYSTEM | KLE | 2007-08-10 | 71 |
| K060889 | SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE | KIF | 2006-10-27 | 210 |
| K060698 | CEMENT-IT ALL PURPOSE, MODEL N97 | EMA | 2006-05-10 | 55 |
| K052106 | SIMILE FLOW | EBF | 2005-10-31 | 89 |
| K052349 | AVANTE LED CURING UNIT, MODEL N44 | EBZ | 2005-10-21 | 53 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pentron Clinical Technologies.
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 Corp. (15 510(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 Clinical Technologies?
FDA lists 13 510(k) clearances under the applicant name “Pentron Clinical Technologies” (first 2002, latest 2009), across 7 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 Clinical Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pentron Clinical Technologies is 71 days.
Which FDA product codes appear under Pentron Clinical Technologies?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 3); EMA (Cement, Dental, 3); KIF (Resin, Root Canal Filling, 2).
Next steps
- See all 13 Pentron Clinical Technologies clearances with predicates and recalls
- Run predicate analysis for product code EBF, Pentron Clinical Technologies'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.