North Pacific Dental, Inc.: FDA clearances and approvals
North Pacific Dental, Inc. has 11 FDA 510(k) clearances (first 1983, latest 1983), across 8 product codes in 1 review panel. Median 510(k) review time: 49 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 |
|---|---|---|---|
| EMA | Cement, Dental | 3 | 3 |
| EKM | Gutta-Percha | 2 | 2 |
| EAT | Tester, Pulp | 1 | 1 |
| EIF | Accessories, Retractor, Dental | 1 | 1 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
| EMR | File, Periodontic | 1 | 1 |
| LFE | Solution, Cold Sterilizing | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (10)
Most recent North Pacific Dental, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K830113 | SEPTOPACK | EMA | 1983-05-09 | 118 |
| K830111 | SEPTOCAL | — | 1983-03-24 | 72 |
| K830106 | UNICIDE | LFE | 1983-03-07 | 55 |
| K830117 | ENDOMET | EMA | 1983-03-01 | 49 |
| K830115 | PAPER POINTS | EKM | 1983-03-01 | 49 |
| K830114 | GUTTA PERCHA POINTS | EKM | 1983-03-01 | 49 |
| K830109 | CIMPAT | EMR | 1983-03-01 | 49 |
| K830105 | VITATHYL | EAT | 1983-03-01 | 49 |
| K830116 | SULCARINGS | EIF | 1983-02-18 | 38 |
| K830112 | HYDROL | EJK | 1983-02-18 | 38 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named North Pacific Dental, Inc..
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 North Pacific Dental, Inc. have?
North Pacific Dental, Inc. has 11 FDA 510(k) clearances (first 1983, latest 1983), across 8 product codes in 1 review panel.
How long does FDA take to clear North Pacific Dental, Inc.'s 510(k)s?
The median time from FDA receipt to decision across North Pacific Dental, Inc.'s cleared 510(k)s is 49 days.
What devices does North Pacific Dental, Inc. make?
Its most frequent FDA product codes are EMA (Cement, Dental, 3); EKM (Gutta-Percha, 2); EAT (Tester, Pulp, 1).
Has North Pacific Dental, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching North Pacific Dental, Inc. Related entities may recall under other names.
Next steps
- See all 11 North Pacific Dental, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EMA, North Pacific Dental, Inc.'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.