Manufacturer registered with FDA
Kettenbach GmbH & Co. KG
ESCHENBURG, Germany. Lists 12 dental device types with FDA across 1 registered establishment, and holds 14 510(k) clearances as applicant.
- Device types listed
- 12
- Brands and models
- 34
- 510(k) clearances
- 142008–2026
- Markets registered in
- 12179 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2000–2026
Registered in 12 markets
Where regulators' registries name Kettenbach GmbH & Co. KG as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Kettenbach GmbH & Co. KG | 14 clearances | 2008–2026 | Below |
| Canada | Health Canada | Registration holder | KETTENBACH GMBH & CO. KG | 48 | 2005–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Kettenbach GmbH & Co. KGKettenbach GmbH & Co. KG. · Kettenbach GmbH & Co.KG · +2 | 23 | 2001–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Kettenbach GmbH & Co. KG | 19 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Kettenbach GmbH & Co. KG | 17 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Kettenbach GmbH & Co KG | 15 | 2023–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | KETTENBACH GMBH & CO. KG | 15 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Kettenbach GmbH & Co.KG | 13 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | KETTENBACH GMBH & CO. KGKettenbach GmbH & Co. KG | 9 | 2006–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | KETTENBACH GMBH & CO. KGKETTENBACH GMBH & CO KG | 8 | 2016–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Kettenbach GmbH & Co. KG | 6 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | KETTENBACH GmbH & CO. KGKETTENBACH GMBH & CO. KG. | 6 | 2008–2021 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Kettenbach GmbH & Co. KG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Impression MaterialELW · Class 2 | Impression materials | Maker | Futar (Futar, Futar D,Futar D Fast, Futar D Slow,Futar Scan) Bite RegistrationIdentium HeavyIdentium Light, Identium MediumIdentium Medium Soft,MaterialsPanasil contact (two in one,Panasil Initial contact (regular,Panasil Monophase 11 morePanasil putty (putty, putty fastPanasil tray (fast 1:1,Panasil tray (fast, soft)plus)regular fast, light, light fastset, putty soft), Panasil bineticsSilginatSilginat Strawberrysoft fast 1:1, soft fast 5:1)x-light, X-light fast)(putty fast, putty soft), | 2008 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Visalys BioCeramic BlockVisalys Bulk FillVisalys Bulk Flow | 2015 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | — | 2023 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | — | 2019 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | ProfisilProfisil Free | 2023 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Visalys Temp | 2013 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Identium AdhesivePanasil Adhesive | 2009 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | MUCOPREN SOFT RELINING SYSTEM | 2007 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Multi Tray | 2010 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | Mucopren Accessory | 2006 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | ProphyProtect | 2026 |
| Dental CementEMA · Class 2 | Dental cements | Maker | Visalys CemCore | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Kettenbach GmbH & Co. KG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Sep 2026 | K262243 | Profisil Free | LBH Cavity Varnish |
| 14 Mar 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 Resin Tooth Shade Material |
| 24 Jul 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 Cavity Varnish |
| 8 Nov 2019 | K191527 | Visalys CemCore, Visalys Cem Core Try In Paste | EMA Dental Cement |
| 9 Oct 2019 | K191523 | Visalys Restorative Primer | KLE Resin Tooth Bonding Agent |
| 29 Sep 2019 | K191524 | Visalys Tooth Primer | KLE Resin Tooth Bonding Agent |
| 25 Mar 2015 | K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X | EBF Resin Tooth Shade Material |
| 27 Dec 2012 | K122039 | KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B | EBG Resin Temporary Crown and Bridge |
| 14 Nov 2011 | K113279 | IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT | ELW Impression Material |
| 1 Oct 2009 | K092867 | IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT | ELW Impression Material |
| 9 Jan 2009 | K083701 | PANASIL INITIAL CONTACT AND PANASIL TRAY | ELW Impression Material |
| 8 Sep 2008 | K082560 | PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT | ELW Impression Material |
| 6 Aug 2008 | K082157 | KETTOSIL AND SILGINAT | ELW Impression Material |
| 1 May 2008 | K081120 | FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS | ELW Impression Material |
Some of these clearances are listed with FDA today by another company: Ultradent Products, Inc. (5), Den-Mat Holdings, LLC (2), Candid Care Co. (1), HEXA Dental (1), Voco GmbH (1).
Also lists devices cleared under other names
Kettenbach GmbH & Co. KG lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Voco GmbH (2), edelweiss dentistry products gmbh (1), Philips Medical Systems International BV (1), Roydent Dental Products, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Oct 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 | edelweiss dentistry products gmbh | EBF Resin Tooth Shade Material |
| 21 Dec 2011 | K113563 | N-HYBRIDE-COMPOSITE LC | Voco GmbH | EBF Resin Tooth Shade Material |
| 21 Dec 2011 | K113444 | N-HYBRIDE-COMPOSITE LC FLOW | Voco GmbH | EBF Resin Tooth Shade Material |
| 9 May 2003 | K030776 | MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL | Philips Medical Systems International BV | ELW Impression Material |
| 13 Nov 1998 | K983357 | MUCOPREN SOFT RELINING SYSTEM | Roydent Dental Products, Inc. | EBI Rebasing Repairing Relining Denture Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| KETTENBACH GMBH & CO KGFDA reg. 9681356 | ESCHENBURG Hesse, Germany | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9022134). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.