Kerr Corporation: FDA clearances and approvals
Kerr Corporation has 41 FDA 510(k) clearances (first 2000, latest 2026), across 11 product codes in 1 review panel. Median 510(k) review time: 86 days. Since 2017 its median was 121 days, against 121 days for all cleared 510(k)s in the same product codes. openFDA lists 64 product recalls by a recalling firm named Kerr Corporation.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 110 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 3 | 112 |
| 2017 | 4 | 210 |
| 2018 | 1 | 89 |
| 2019 | 1 | 121 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 121 |
| 2023 | 1 | 115 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 118 |
Review time against the same product codes
Since 2017, Kerr Corporation's cleared 510(k)s took a median 121 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 9 | 9 |
| ELW | Material, Impression | 8 | 8 |
| EBZ | Activator, Ultraviolet, For Polymerization | 6 | 6 |
| MVL | Cord, Retraction | 5 | 5 |
| KLE | Agent, Tooth Bonding, Resin | 4 | 4 |
| EMA | Cement, Dental | 3 | 3 |
| KIF | Resin, Root Canal Filling | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| MZW | Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief | 1 | 1 |
| NTK | Light Transmission Caries Detector | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (41)
Most recent Kerr Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252890 | ZenSeal Pro | KIF | 2026-01-07 | 118 |
| K222830 | Rainbow 360 | KLE | 2023-01-12 | 115 |
| K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow | EBF | 2022-08-31 | 121 |
| K191548 | Nexus Universal Self-Cure | EMA | 2019-10-11 | 121 |
| K182162 | OptiBond eXTRa Universal | KLE | 2018-11-07 | 89 |
| K162948 | Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials | MVL | 2017-08-08 | 291 |
| K163064 | Demi Ultra | EBZ | 2017-07-18 | 258 |
| K162536 | GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord | MVL | 2017-02-03 | 144 |
| K162164 | GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord | MVL | 2017-01-13 | 163 |
| K162436 | EndoVac Pure | NYL | 2016-12-21 | 112 |
31 earlier clearances. See the full list in Caduvo.
Recalls
64 product recalls in 16 recall events; 0 initiated in the last five years. Most recent: 2014-05-29.
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 Kerr Corporation have?
Kerr Corporation has 41 FDA 510(k) clearances (first 2000, latest 2026), across 11 product codes in 1 review panel.
How long does FDA take to clear Kerr Corporation's 510(k)s?
The median time from FDA receipt to decision across Kerr Corporation's cleared 510(k)s is 86 days. Since 2017: 121 days, versus 121 days for all cleared 510(k)s in the same product codes.
What devices does Kerr Corporation make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 9); ELW (Material, Impression, 8); EBZ (Activator, Ultraviolet, For Polymerization, 6).
Has Kerr Corporation had device recalls?
openFDA lists 64 product recalls in 16 recall events by a recalling firm whose name matches Kerr Corporation; the most recent began 2014-05-29. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 41 Kerr Corporation clearances with predicates and recalls
- Run predicate analysis for product code EBF, Kerr Corporation'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.