Macrochem Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Macrochem Corp.” (first 1986, latest 1989), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 69 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 |
|---|---|---|---|
| EMA | Cement, Dental | 2 | 2 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 | 1 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
Review panels
- Dental (5)
Most recent Macrochem Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K890623 | FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT | EMA | 1989-04-17 | 69 |
| K890608 | FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT | EMA | 1989-04-17 | 70 |
| K890494 | FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS | EBC | 1989-03-29 | 57 |
| K880562 | ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT | DYH | 1988-08-19 | 190 |
| K861546 | REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT | EBF | 1986-05-21 | 26 |
Recalls
openFDA lists no recalls under a recalling firm named Macrochem Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Macrochem Corp.?
FDA lists 5 510(k) clearances under the applicant name “Macrochem Corp.” (first 1986, latest 1989), across 4 product codes 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 Macrochem Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Macrochem Corp. is 69 days.
Which FDA product codes appear under Macrochem Corp.?
The most frequent FDA product codes under this applicant name are EMA (Cement, Dental, 2); DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 1); EBC (Sealant, Pit And Fissure, And Conditioner, 1).
Next steps
- See all 5 Macrochem Corp. clearances with predicates and recalls
- Run predicate analysis for product code EMA, Macrochem Corp.'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.