Kettenbach GmbH & Co KG
ESCHENBURG Hesse, DE
KETTENBACH GMBH & CO KG appears in FDA device records in ESCHENBURG Hesse, DE. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Kettenbach GmbH & Co KG between 2008 and 2025. The busiest year on record is 2008, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 3 |
| 2009 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2015 | 1 |
| 2019 | 3 |
| 2023 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K191527 | Visalys CemCore, Visalys Cem Core Try In Paste | EMA | Substantially Equivalent | |
| K191523 | Visalys Restorative Primer | KLE | Substantially Equivalent | |
| K191524 | Visalys Tooth Primer | KLE | Substantially Equivalent | |
| K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X | EBF | Substantially Equivalent | |
| K122039 | KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B | EBG | Substantially Equivalent | |
| K113279 | IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT | ELW | Substantially Equivalent | |
| K092867 | IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT | ELW | Substantially Equivalent | |
| K083701 | PANASIL INITIAL CONTACT AND PANASIL TRAY | ELW | Substantially Equivalent | |
| K082560 | PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT | ELW | Substantially Equivalent | |
| K082157 | KETTOSIL AND SILGINAT | ELW | Substantially Equivalent | |
| K081120 | FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS | ELW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9681356 | 3006349398 | KETTENBACH GMBH & CO KG | IM HEERFELD 7, ESCHENBURG Hesse 35713 DE | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KLEAgent, Tooth Bonding, Resin
- EMACement, Dental
- EBGCrown And Bridge, Temporary, Resin
- ELWMaterial, Impression
- EBHMaterial, Impression Tray, Resin
- EBFMaterial, Tooth Shade, Resin
- EBIResin, Denture, Relining, Repairing, Rebasing
- EBCSealant, Pit And Fissure, And Conditioner
- EIDSyringe, Restorative And Impression Material
- EHYTray, Impression, Preformed
- LBHVarnish, Cavity
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain