Pacific Dental Corp.: FDA clearances and approvals
Pacific Dental Corp. has 22 FDA 510(k) clearances (first 1980, latest 1982), across 20 product codes in 1 review panel. Median 510(k) review time: 19 days.
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 |
|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | 2 | 2 |
| EAX | Mirror, Mouth | 1 | 1 |
| EAZ | Light, Operating, Dental | 1 | 1 |
| ECB | Unit, Syringe, Air And/Or Water | 1 | 1 |
| EFL | Forceps, Dressing, Dental | 1 | 1 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | 1 |
| EHZ | Evacuator, Oral Cavity | 1 | 1 |
| EIA | Unit, Operative Dental | 1 | 1 |
| EIG | Retractor, All Types | 1 | 1 |
| EJI | Syringe, Cartridge | 1 | 1 |
Plus 10 more product codes.
Review panels
- Dental (20)
Most recent Pacific Dental Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K821782 | BEACH ANESTHETIC SYRINGE CARTR. TYPE | EJI | 1982-07-20 | 33 |
| K821790 | BEACH EXCAVATOR'S NO. 1 & NO. 2 | EKD | 1982-07-06 | 19 |
| K821789 | BEACH CURETTE NO. 2 AND NO. 3 T.G. | EMS | 1982-07-06 | 19 |
| K821788 | BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT | EMJ | 1982-07-06 | 19 |
| K821787 | BEACH SURGICAL PLIERS NON-HOOK | EJY | 1982-07-06 | 19 |
| K821786 | BEACH SCALERS | EMN | 1982-07-06 | 19 |
| K821785 | BEACH AMALGAM CARVER | EKH | 1982-07-06 | 19 |
| K821784 | BEACH GINGIVAL RETRACTION INSTR. TYPE B | EIG | 1982-07-06 | 19 |
| K821783 | BEACH SILICATE FILLING & LINING APPLIC. | — | 1982-07-06 | 19 |
| K821780 | BEACH EXPLORER NO. 23T.G. | EKB | 1982-07-06 | 19 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pacific Dental Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Pacific Dental Corp. have?
Pacific Dental Corp. has 22 FDA 510(k) clearances (first 1980, latest 1982), across 20 product codes in 1 review panel.
How long does FDA take to clear Pacific Dental Corp.'s 510(k)s?
The median time from FDA receipt to decision across Pacific Dental Corp.'s cleared 510(k)s is 19 days.
What devices does Pacific Dental Corp. make?
Its most frequent FDA product codes are EKX (Handpiece, Direct Drive, Ac-Powered, 2); EAX (Mirror, Mouth, 1); EAZ (Light, Operating, Dental, 1).
Has Pacific Dental Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pacific Dental Corp. Related entities may recall under other names.
Next steps
- See all 22 Pacific Dental Corp. clearances with predicates and recalls
- Run predicate analysis for product code EKX, Pacific Dental Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.