Data / Medical devices / Germany / Kettenbach GMBH & Co KG
Kettenbach GMBH & Co KG: FDA-registered device maker in ESCHENBURG Hesse, Germany, 18 510(k) clearances
Kettenbach GMBH & Co KG is registered with the FDA (registration 9681356) in ESCHENBURG Hesse, Germany. It lists 12 device types. The FDA files 18 510(k) clearances under its listings, the newest dated September 3, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9681356
- FEI number
- 3006349398
- Address
- Im Heerfeld 7, ESCHENBURG Hesse, Germany, 35713
- Owner or operator
- KETTENBACH GMBH & CO KG (9022134)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- April 10, 2006
- Registered through
- 2026
- Brand names listed
- (putty fast, putty soft),, Futar (Futar, Futar D,, Futar D Fast, Futar D Slow,, Futar Scan) Bite Registration, Identium Adhesive, Identium Heavy, Identium Light, Identium Medium, Identium Medium Soft, and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Manufacturer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 3, 2026 | K262243 | Profisil Free | LBH | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| March 14, 2025 | 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 | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| October 18, 2024 | K241131 | edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK | EBF | Substantially Equivalent | Edelweiss Dentistry Products GmbH | accessdata.fda.gov |
| July 24, 2023 | 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 | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| November 8, 2019 | K191527 | Visalys CemCore, Visalys Cem Core Try In Paste | EMA | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| October 9, 2019 | K191523 | Visalys Restorative Primer | KLE | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| September 29, 2019 | K191524 | Visalys Tooth Primer | KLE | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| March 25, 2015 | K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X | EBF | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| December 27, 2012 | K122039 | KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B | EBG | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| December 21, 2011 | K113563 | N-HYBRIDE-COMPOSITE LC | EBF | Substantially Equivalent | Voco GmbH | accessdata.fda.gov |
| December 21, 2011 | K113444 | N-HYBRIDE-COMPOSITE LC FLOW | EBF | Substantially Equivalent | Voco GmbH | accessdata.fda.gov |
| October 1, 2009 | K092867 | IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT | ELW | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| January 9, 2009 | K083701 | PANASIL INITIAL CONTACT AND PANASIL TRAY | ELW | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| September 8, 2008 | K082560 | PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT | ELW | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| August 6, 2008 | K082157 | KETTOSIL AND SILGINAT | ELW | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| May 1, 2008 | K081120 | FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS | ELW | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| May 9, 2003 | K030776 | MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL | ELW | Substantially Equivalent | Discus Dental, Inc. | accessdata.fda.gov |
| November 13, 1998 | K983357 | MUCOPREN SOFT RELINING SYSTEM | EBI | Substantially Equivalent | Roydent Dental Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Impression Tray, Resin
- All makers of Syringe, Restorative And Impression Material
- All makers of Sealant, Pit And Fissure, And Conditioner
- All makers of Material, Tooth Shade, Resin
- All makers of Agent, Polishing, Abrasive, Oral Cavity
- All makers of Varnish, Cavity
Updated September 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.