Kulzer, Inc.: FDA filings under this applicant name
FDA lists 38 510(k) clearances under the applicant name “Kulzer, Inc.” (first 1981, latest 2026), across 11 product codes in 1 review panel. Median 510(k) review time under this name: 67 days. Since 2017 the median was 169 days, against 121 days for all cleared 510(k)s in the same product codes. 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 | 1 | 50 |
| 2023 | 1 | 183 |
| 2024 | 2 | 181 |
| 2025 | 2 | 140 |
| 2026 | 1 | 1 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kulzer, Inc. took a median 169 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 | 19 | 19 |
| EBG | Crown And Bridge, Temporary, Resin | 3 | 3 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 3 | 3 |
| EBZ | Activator, Ultraviolet, For Polymerization | 3 | 3 |
| EMA | Cement, Dental | 3 | 3 |
| EBH | Material, Impression Tray, Resin | 2 | 2 |
| EGD | Wax, Dental, Intraoral | 1 | 1 |
| EJJ | Alloy, Amalgam | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (38)
Most recent Kulzer, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | EBF | 2026-03-11 | 1 |
| K254063 | iCEM Universal Plus | EMA | 2025-12-19 | 2 |
| K243910 | Retraxil | MVL | 2025-09-24 | 279 |
| K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active | EBF | 2024-09-17 | 193 |
| K233868 | dima Print Teeth & Temp | EBG | 2024-05-23 | 169 |
| K230644 | Signum opaque F | EBF | 2023-09-07 | 183 |
| K220605 | Venus Bulk Flow ONE | EBF | 2022-04-21 | 50 |
| K905058 | PALAVIT L | EBH | 1991-06-06 | 210 |
| K904928 | PALAVIT GLC | EGD | 1991-06-06 | 218 |
| K910263 | CHARISMA | EBF | 1991-06-03 | 132 |
28 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kulzer, Inc..
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 Kulzer, Inc.?
FDA lists 38 510(k) clearances under the applicant name “Kulzer, Inc.” (first 1981, latest 2026), across 11 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 Kulzer, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kulzer, Inc. is 67 days. Since 2017: 169 days, versus 121 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kulzer, Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 19); EBG (Crown And Bridge, Temporary, Resin, 3); EBI (Resin, Denture, Relining, Repairing, Rebasing, 3).
Next steps
- See all 38 Kulzer, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Kulzer, Inc.'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.