Pac-Dent International, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Pac-Dent International, Inc.” (first 2013, latest 2017), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 146 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 |
|---|---|---|
| 2013 | 1 | 154 |
| 2014 | 1 | 123 |
| 2015 | 3 | 126 |
| 2016 | 3 | 146 |
| 2017 | 1 | 389 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Pac-Dent International, Inc. took a median 389 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KJJ | Cleanser, Root Canal | 3 | 3 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| LBH | Varnish, Cavity | 1 | 1 |
| MVL | Cord, Retraction | 1 | 1 |
| PEM | Dental Barriers And Sleeves | 1 | 1 |
Review panels
- Dental (9)
Most recent Pac-Dent International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162662 | GingiDent Gingival Retraction Paste | MVL | 2017-10-20 | 389 |
| K160577 | PacEndo Chlorhexidine | KJJ | 2016-07-25 | 146 |
| K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | PEM | 2016-03-03 | 310 |
| K153528 | PacEndo EDTA | KJJ | 2016-02-01 | 54 |
| K151852 | PacEndo Sodium Hyprochlorite | KJJ | 2015-11-10 | 126 |
| K151150 | Elements | ELW | 2015-07-28 | 89 |
| K141717 | PACSEAL PIT & FISSURE SEALANT | EBC | 2015-03-09 | 257 |
| K141422 | PROFLUORO FLUORIDE VARNISH | LBH | 2014-09-30 | 123 |
| K130672 | OPTIFLOW II FLOWABLE COMPOSITE, LC | EBF | 2013-08-13 | 154 |
Recalls
openFDA lists no recalls under a recalling firm named Pac-Dent International, Inc..
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.
- Pac-Dent, Inc. (8 510(k)s)
- Pac-Dent International (Suzhou), Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pac-Dent International, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Pac-Dent International, Inc.” (first 2013, latest 2017), 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 Pac-Dent International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pac-Dent International, Inc. is 146 days.
Which FDA product codes appear under Pac-Dent International, Inc.?
The most frequent FDA product codes under this applicant name are KJJ (Cleanser, Root Canal, 3); EBC (Sealant, Pit And Fissure, And Conditioner, 1); EBF (Material, Tooth Shade, Resin, 1).
Next steps
- See all 9 Pac-Dent International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KJJ, Pac-Dent International, 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, 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.