Pac-Dent, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Pac-Dent, Inc.” (first 2020, latest 2022), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 239 days. Since 2017 the median was 239 days, against 134 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 |
|---|---|---|
| 2020 | 1 | 147 |
| 2021 | 5 | 184 |
| 2022 | 2 | 710 |
| 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, Inc. took a median 239 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| KJJ | Cleanser, Root Canal | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
| OXZ | Pediatric/Child Facemask | 1 | 1 |
Review panels
- Dental (6)
- General Hospital (2)
Most recent Pac-Dent, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202674 | Medidenta High Speed Handpieces | EFB | 2022-12-12 | 818 |
| K202920 | OptiComp | EBF | 2022-05-25 | 603 |
| K202831 | The iMask Child's Face Mask | OXZ | 2021-08-26 | 335 |
| K210189 | Pac-Dent Denture Base Resin | EBI | 2021-07-28 | 184 |
| K210412 | Pac-Dent Ceramic Nanohybrid Resin | EBF | 2021-07-26 | 165 |
| K210186 | PacBond One | KLE | 2021-07-16 | 172 |
| K201182 | iMask Disposable Surgical Face Mask | FXX | 2021-02-19 | 294 |
| K200330 | RC-Prime Root Canal Preparation Cream | KJJ | 2020-07-06 | 147 |
Recalls
openFDA lists no recalls under a recalling firm named Pac-Dent, 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 International, Inc. (9 510(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, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Pac-Dent, Inc.” (first 2020, latest 2022), across 7 product codes in 2 review panels. 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pac-Dent, Inc. is 239 days. Since 2017: 239 days, versus 134 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Pac-Dent, Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 2); EBI (Resin, Denture, Relining, Repairing, Rebasing, 1); EFB (Handpiece, Air-Powered, Dental, 1).
Next steps
- See all 8 Pac-Dent, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Pac-Dent, 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.