Pemaco, Inc.: FDA clearances and approvals
Pemaco, Inc. has 7 FDA 510(k) clearances (first 1989, latest 1991), across 1 product code in 1 review panel. Median 510(k) review time: 61 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 |
|---|---|---|---|
| EGD | Wax, Dental, Intraoral | 7 | 7 |
Review panels
- Dental (7)
Most recent Pemaco, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910676 | INTRAORAL DENTAL WAX | EGD | 1991-08-21 | 187 |
| K895566 | PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT | EGD | 1989-11-06 | 61 |
| K895564 | PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD | EGD | 1989-11-06 | 61 |
| K895563 | PEMACO BITE WAX SHEETS | EGD | 1989-11-06 | 61 |
| K895562 | PEMACO 2000 INTRAORAL DENTAL WAX | EGD | 1989-11-06 | 61 |
| K895561 | PEMACO 3000 INTRAORAL DENTAL WAX | EGD | 1989-11-06 | 61 |
| K895565 | PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD | EGD | 1989-10-24 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Pemaco, 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 Pemaco, Inc. have?
Pemaco, Inc. has 7 FDA 510(k) clearances (first 1989, latest 1991), across 1 product code in 1 review panel.
How long does FDA take to clear Pemaco, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Pemaco, Inc.'s cleared 510(k)s is 61 days.
What devices does Pemaco, Inc. make?
Its most frequent FDA product codes are EGD (Wax, Dental, Intraoral, 7).
Has Pemaco, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pemaco, Inc. Related entities may recall under other names.
Next steps
- See all 7 Pemaco, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EGD, Pemaco, 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.