Cmp Industries, LLC: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cmp Industries, LLC” (first 1990, latest 2017), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 | 2 | 246 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cmp Industries, LLC took a median 246 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 5 | 5 |
| EJH | Alloy, Metal, Base | 1 | 1 |
| PYQ | Rfid Chip For Dental Appliance | 1 | 1 |
Review panels
- Dental (6)
- General Hospital (1)
Most recent Cmp Industries, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170423 | DentureID Microchip | PYQ | 2017-10-25 | 254 |
| K170375 | Nobilplast Denture Resin | EBI | 2017-10-02 | 237 |
| K072851 | POLYSTAR 79 DENTURE BASE RESIN | EBI | 2008-02-20 | 139 |
| K072402 | FLEX-STAR V | EBI | 2007-10-19 | 53 |
| K033020 | IMPAK ACRYLIC REPAIR RESIN LIQUID | EBI | 2003-12-19 | 84 |
| K953594 | VULCAN | EJH | 1995-09-05 | 36 |
| K902972 | FLEXOR (DENTURE ACRYLIC RELINE MATERIAL) | EBI | 1990-10-04 | 90 |
Recalls
6 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2018-09-12.
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 Cmp Industries, LLC?
FDA lists 7 510(k) clearances under the applicant name “Cmp Industries, LLC” (first 1990, latest 2017), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cmp Industries, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cmp Industries, LLC is 90 days.
Which FDA product codes appear under Cmp Industries, LLC?
The most frequent FDA product codes under this applicant name are EBI (Resin, Denture, Relining, Repairing, Rebasing, 5); EJH (Alloy, Metal, Base, 1); PYQ (Rfid Chip For Dental Appliance, 1).
Next steps
- See all 7 Cmp Industries, LLC clearances with predicates and recalls
- Run predicate analysis for product code EBI, Cmp Industries, LLC'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.