Cosmedent, Inc.: FDA clearances and approvals
Cosmedent, Inc. has 28 FDA 510(k) clearances (first 1986, latest 2024), across 10 product codes in 1 review panel. Median 510(k) review time: 77 days. Since 2017 its median was 74 days, against 126 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named Cosmedent, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 81 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 59 |
| 2022 | 1 | 60 |
| 2023 | 0 | — |
| 2024 | 1 | 131 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Cosmedent, Inc.'s cleared 510(k)s took a median 74 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 12 | 12 |
| EMA | Cement, Dental | 4 | 4 |
| EBD | Coating, Filling Material, Resin | 3 | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 2 | 2 |
| KLE | Agent, Tooth Bonding, Resin | 2 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| LBH | Varnish, Cavity | 1 | 1 |
| MQC | Mouthguard, Prescription | 1 | 1 |
Review panels
- Dental (28)
Most recent Cosmedent, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240714 | Insure® Universal; Insure® Universal Automix | EMA | 2024-07-24 | 131 |
| K222435 | Renamel® Microhybrid ;Renamel® Flowable Microhybrid | EBF | 2022-10-11 | 60 |
| K211259 | Renamel Bulkfill | EBF | 2021-06-24 | 59 |
| K172707 | Renamel Microfill | EBF | 2017-12-05 | 88 |
| K163480 | Renamel NANO +plus | EBF | 2017-02-24 | 74 |
| K092730 | COSMEDENT BRUSHABLE COMPOSITE | EBF | 2009-11-20 | 77 |
| K070583 | NANO COMPOSITE | EBF | 2007-04-16 | 46 |
| K060881 | TEMPORARY CROWN & BRIDGE RESIN | EBG | 2006-05-16 | 46 |
| K052263 | MULTIPLE (TOOTH DESENSITIZER) | LBH | 2005-12-16 | 119 |
| K052501 | MULTIPLE RESIN TOOTH BONDING AGENT | KLE | 2005-10-21 | 38 |
18 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2023-07-20.
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 Cosmedent, Inc. have?
Cosmedent, Inc. has 28 FDA 510(k) clearances (first 1986, latest 2024), across 10 product codes in 1 review panel.
How long does FDA take to clear Cosmedent, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cosmedent, Inc.'s cleared 510(k)s is 77 days. Since 2017: 74 days, versus 126 days for all cleared 510(k)s in the same product codes.
What devices does Cosmedent, Inc. make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 12); EMA (Cement, Dental, 4); EBD (Coating, Filling Material, Resin, 3).
Has Cosmedent, Inc. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Cosmedent, Inc; the most recent began 2023-07-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 28 Cosmedent, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Cosmedent, 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.