Pacific Union Dental, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Pacific Union Dental, Inc.” (first 1986, latest 1986), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 73 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 |
|---|---|---|---|
| ELW | Material, Impression | 2 | 2 |
| EIK | Carver, Wax, Dental | 1 | 1 |
| EIS | Remover, Crown | 1 | 1 |
| JES | Floss, Dental | 1 | 1 |
Review panels
- Dental (5)
Most recent Pacific Union Dental, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K863500 | STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR | EIS | 1986-09-22 | 13 |
| K860817 | ROOT CANAL ORGANIZER | EIK | 1986-03-17 | 13 |
| K855113 | FLOSS HOLDER (PLASTIC) | JES | 1986-03-06 | 73 |
| K855112 | DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS | ELW | 1986-03-06 | 73 |
| K855111 | DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES | ELW | 1986-03-06 | 73 |
Recalls
openFDA lists no recalls under a recalling firm named Pacific Union Dental, 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.
- Pacific Biotech, Inc. (29 510(k)s)
- Pacific Hemostasis (29 510(k)s)
- Pacific Dental Corp. (22 510(k)s)
- Pacific Device, Inc. (5 510(k)s)
- Pacific Consolidated Industries, LLC (4 510(k)s)
- Pacific Materials and Interfaces (3 510(k)s)
- Pacific Andrology, Inc. (2 510(k)s)
- Pacific Consolidated Industries Llp (2 510(k)s)
- Pacific Delta Medical Supply (2 510(k)s)
- Pacific Implant, Inc. (2 510(k)s)
- Pacific Medico Co., Ltd. (2 510(k)s)
- Pacific Rim Dental, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pacific Union Dental, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Pacific Union Dental, Inc.” (first 1986, latest 1986), across 4 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 Pacific Union Dental, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pacific Union Dental, Inc. is 73 days.
Which FDA product codes appear under Pacific Union Dental, Inc.?
The most frequent FDA product codes under this applicant name are ELW (Material, Impression, 2); EIK (Carver, Wax, Dental, 1); EIS (Remover, Crown, 1).
Next steps
- See all 5 Pacific Union Dental, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ELW, Pacific Union Dental, 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.