North American Alloys, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “North American Alloys, Inc.” (first 1985, latest 1999), across 1 product code in 1 review panel. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| EJH | Alloy, Metal, Base | 5 | 5 |
Review panels
- Dental (5)
Most recent North American Alloys, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993344 | P10 SPECIAL | EJH | 1999-11-15 | 41 |
| K873661 | CHROME-COBALT BASE DENTAL ALLOY | EJH | 1987-11-16 | 67 |
| K862930 | PERFECT ONE | EJH | 1986-10-24 | 81 |
| K853845 | ALLOY B | EJH | 1985-11-19 | 64 |
| K853498 | PERFECT 10 | EJH | 1985-09-27 | 38 |
Recalls
openFDA lists no recalls under a recalling firm named North American Alloys, 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.
- North American Instrument Corp. (28 510(k)s)
- North American Sterilization & Packaging Co. (16 510(k)s)
- North American Philips Corp. (15 510(k)s)
- North Pacific Dental, Inc. (11 510(k)s)
- North East Monitoring, Inc. (10 510(k)s)
- North American Technical Services Corp. (9 510(k)s)
- North American Biologicals, Inc. (6 510(k)s)
- North American Medical Products, Inc. (6 510(k)s)
- North American Science Assoc., Inc. (6 510(k)s)
- North Coast Medi-Tek (6 510(k)s)
- North American Scientific, Inc. (4 510(k)s)
- North Eos Industries, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under North American Alloys, Inc.?
FDA lists 5 510(k) clearances under the applicant name “North American Alloys, Inc.” (first 1985, latest 1999), across 1 product code 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 North American Alloys, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name North American Alloys, Inc. is 64 days.
Which FDA product codes appear under North American Alloys, Inc.?
The most frequent FDA product codes under this applicant name are EJH (Alloy, Metal, Base, 5).
Next steps
- See all 5 North American Alloys, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJH, North American Alloys, 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.