Macdonald Metals and Ceramics: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Macdonald Metals and Ceramics” (first 1989, latest 1989), across 1 product code in 1 review panel. Median 510(k) review time under this name: 26 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | 22 | 22 |
Review panels
- Dental (22)
Most recent Macdonald Metals and Ceramics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K891530 | M-77 GOLD BASE DENTAL ALLOY | EJT | 1989-04-14 | 28 |
| K891516 | C-89 GOLD BASE DENTAL ALLOY | EJT | 1989-04-14 | 28 |
| K891535 | P-C PALLADIUM BASE DENTAL ALLOY | EJT | 1989-04-12 | 26 |
| K891534 | M-75 GOLD BASE DENTAL ALLOY | EJT | 1989-04-12 | 26 |
| K891533 | M-74 GOLD BASE DENTAL ALLOY | EJT | 1989-04-12 | 26 |
| K891532 | M-70 GOLD BASE DENTAL ALLOY | EJT | 1989-04-12 | 26 |
| K891531 | M-50 GOLD BASE DENTAL ALLOY | EJT | 1989-04-12 | 26 |
| K891529 | M-W SILVER PALLADIUM BASE DENTAL ALLOY | EJT | 1989-04-12 | 26 |
| K891528 | M-65 GOLD BASE DENTAL ALLOY | EJT | 1989-04-12 | 26 |
| K891527 | M-60 GOLD BASE DENTAL ALLOY | EJT | 1989-04-12 | 26 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Macdonald Metals and Ceramics.
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.
- Macdonald Medical Devices, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Macdonald Metals and Ceramics?
FDA lists 22 510(k) clearances under the applicant name “Macdonald Metals and Ceramics” (first 1989, latest 1989), 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 Macdonald Metals and Ceramics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Macdonald Metals and Ceramics is 26 days.
Which FDA product codes appear under Macdonald Metals and Ceramics?
The most frequent FDA product codes under this applicant name are EJT (Alloy, Gold-Based Noble Metal, 22).
Next steps
- See all 22 Macdonald Metals and Ceramics clearances with predicates and recalls
- Run predicate analysis for product code EJT, Macdonald Metals and Ceramics'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.