Kettenbach GmbH & Co. KG: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Kettenbach GmbH & Co. KG” (first 2008, latest 2026), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 54 days. Since 2017 the median was 116 days, against 120 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 | 1 | 169 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 147 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 3 | 121 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 167 |
| 2024 | 0 | — |
| 2025 | 1 | 43 |
| 2026 | 1 | 64 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kettenbach GmbH & Co. KG took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ELW | Material, Impression | 6 | 6 |
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| KLE | Agent, Tooth Bonding, Resin | 2 | 2 |
| LBH | Varnish, Cavity | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
Review panels
- Dental (14)
Most recent Kettenbach GmbH & Co. KG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262243 | Profisil Free | LBH | 2026-09-03 | 64 |
| K250267 | Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) | EBF | 2025-03-14 | 43 |
| K230333 | Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) | LBH | 2023-07-24 | 167 |
| K191527 | Visalys CemCore, Visalys Cem Core Try In Paste | EMA | 2019-11-08 | 151 |
| K191523 | Visalys Restorative Primer | KLE | 2019-10-09 | 121 |
| K191524 | Visalys Tooth Primer | KLE | 2019-09-29 | 111 |
| K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X | EBF | 2015-03-25 | 147 |
| K122039 | KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B | EBG | 2012-12-27 | 169 |
| K113279 | IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT | ELW | 2011-11-14 | 7 |
| K092867 | IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT | ELW | 2009-10-01 | 13 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kettenbach GmbH & Co. KG.
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 Kettenbach GmbH & Co. KG?
FDA lists 14 510(k) clearances under the applicant name “Kettenbach GmbH & Co. KG” (first 2008, latest 2026), across 6 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 Kettenbach GmbH & Co. KG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kettenbach GmbH & Co. KG is 54 days. Since 2017: 116 days, versus 120 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kettenbach GmbH & Co. KG?
The most frequent FDA product codes under this applicant name are ELW (Material, Impression, 6); EBF (Material, Tooth Shade, Resin, 2); KLE (Agent, Tooth Bonding, Resin, 2).
Next steps
- See all 14 Kettenbach GmbH & Co. KG clearances with predicates and recalls
- Run predicate analysis for product code ELW, Kettenbach GmbH & Co. KG'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.