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Sign in to claim this brandKettenbach GmbH & Co. KG
Germany·DE-MF-000005014
Last updated May 30, 2026
What Kettenbach GmbH & Co. KG makes
Kettenbach GmbH & Co. KG produces dental materials and tools, including silicone and other dental impression materials, dental composite resins, and professional-grade tooth-desensitizing coatings. Their portfolio also includes temporary crowns and bridges, single-use mixing nozzles and application tools, and disposable impression trays. Specific products include flowable composites, try-in pastes, and specialized mixing tips for dental procedures.
The company’s devices are classified as Class I, Class II, or Class IIa under EU and U.S. regulations, with listings in the EUDAMED database, FDA’s 510(k) clearance records, and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in Germany.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Kettenbach GmbH & Co. KG primarily manufacture?
Kettenbach GmbH & Co. KG specializes in dental materials and tools. Their portfolio includes silicone and other dental impression materials, dental composite resins, professional tooth-desensitizing coatings, temporary crowns and bridges, and single-use items like mixing nozzles, application tools, and impression trays. These products are designed for use in dental procedures, such as impressions, restorations, and cavity treatments.
Where is Kettenbach GmbH & Co. KG based, and how does that affect their regulatory standing?
Kettenbach GmbH & Co. KG is based in Germany, which means their devices are subject to EU medical device regulations. Their products are classified under EU classifications (Class I, Class II, or Class IIa) and are listed in the EUDAMED database, demonstrating compliance with EU regulatory requirements. Additionally, their devices are also tracked in the FDA’s 510(k) clearance records and UDI system in the U.S., reflecting their global market presence.
Which regulatory registries list Kettenbach GmbH & Co. KG’s devices?
Kettenbach GmbH & Co. KG’s devices are listed in multiple regulatory databases to ensure transparency and compliance. Their products appear in the EUDAMED database, which tracks EU-authorized medical devices, as well as the FDA’s 510(k) clearance records and the FDA’s Unique Device Identifier (UDI) system in the United States. These listings help healthcare professionals and regulators verify the authorized status of their devices.
How are Kettenbach GmbH & Co. KG’s devices classified under EU and U.S. regulations?
Kettenbach GmbH & Co. KG’s devices are classified under EU and U.S. medical device regulations based on their risk levels. In the EU, their products fall into Class I (low risk), Class II (moderate risk), or Class IIa (moderate risk with additional controls). In the U.S., the same classifications apply under FDA guidelines, ensuring appropriate oversight and authorization processes are followed for each device type.
Why do some of Kettenbach GmbH & Co. KG’s devices require single-use applications, like mixing nozzles or impression trays?
Kettenbach GmbH & Co. KG offers single-use devices like mixing nozzles and impression trays to enhance hygiene and reduce cross-contamination in dental settings. Single-use items are designed for one-time application, minimizing the risk of bacterial transfer between patients. This approach aligns with strict infection control protocols in dentistry, ensuring safety and compliance with regulatory standards for reusable and disposable medical devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Germany
- Address
- 7, Im Heerfeld , Eschenburg, Germany
- Website
- www.kettenbach-dental.de
- —
- —
- [email protected]
- Phone
- +49 2774 705 0
- PRRC Contact
- Maximilian Meier
- EUDAMED SRN
- DE-MF-000005014
- FDA FEI Number
- —
- DUNS Number
- 316803246
Catalogue (362)
Page 6 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Identium Adhesive | 14204 | FDA UDI | Class I | Active |
| Panasil Adhesive | 14101 | FDA UDI | Class I | Active |
| Profisil | 14832 | FDA UDI | Class II | Active |
| Visalys Veneer | 28442M | FDA UDI | Class II | Unknown |
| Visalys Veneer | 28453 | FDA UDI | Class II | Unknown |
| Visalys Veneer | 28414L | FDA UDI | Class II | Unknown |
| Visalys Veneer | 28460 | FDA UDI | Class II | Unknown |
| Identium | 13700 | FDA UDI | Class II | Active |
| Mixing Tips | 22020 | FDA UDI | Class I | Unknown |
| Visalys Fill | 15002 | FDA UDI | Class II | Active |
| Visalys Restorative Primer | 13581 | FDA UDI | Class II | Active |
| Panasil | 13431 | FDA UDI | Class II | Active |
| Visalys Veneer | 28413-23M | FDA UDI | Class II | Unknown |
| Visalys Veneer | 28422S | FDA UDI | Class II | Unknown |
| Panasil | 1347111 | FDA UDI | Class II | Unknown |
| Panasil | 13402 | FDA UDI | Class II | Unknown |
| Visalys Veneer | 28422M | FDA UDI | Class II | Unknown |
| Visalys Core | 13870 | FDA UDI | Class II | Active |
| Visalys Veneer | 28412S | FDA UDI | Class II | Unknown |
| Visalys Veneer | 28441S | FDA UDI | Class II | Unknown |
| Mixing Tips | 01139 | FDA UDI | Class I | Active |
| Mixing Tips | 13789 | FDA UDI | Class I | Active |
| Visalys Veneer | 28442S | FDA UDI | Class II | Unknown |
| Dynamic Mixers | 17902 | FDA UDI | Class I | Active |
| Visalys Veneer | 28422L | FDA UDI | Class II | Unknown |
| Visalys Veneer | 28411S | FDA UDI | Class II | Unknown |
| Visalys Veneer | 28470 | FDA UDI | Class II | Unknown |
| Panasil contact plus X-Light Promotion pack | 2814411 | EUDAMEDFDA UDI | Class IIa | Active |
| Identium Heavy Intro pack | 1472411 | EUDAMED | Class IIa | Active |
| Mucopren Adhesive | 14203 | EUDAMEDFDA UDI | Class I | Active |
| Panasil binetics Putty Soft Refill pack | 14703 | EUDAMEDFDA UDI | Class IIa | Active |
| Futar D Slow Normal pack | 1195111 | EUDAMEDFDA UDI | Class IIa | Active |
| Identium Medium Fast Refill pack | 14719 | EUDAMEDFDA UDI | Class IIa | Active |
| Silginat Bulk pack | 13847 | EUDAMEDFDA UDI | Class IIa | Active |
| Visalys Temp | 13780 | EUDAMEDFDA UDI | Class IIa | Active |
| Mucopren | 15677 | EUDAMED | Class IIa | Active |
| Silginat Refill pack | 14770 | EUDAMED | Class IIa | Active |
| Silginat Normal pack | 13846 | EUDAMEDFDA UDI | Class IIa | Active |
| Futar Easy Fast Normal pack | 1192411 | EUDAMEDFDA UDI | Class IIa | Active |
| VSXE One Intro pack | 14781 | EUDAMED | Class IIa | Active |
| Panasil binetics Putty Fast Intro pack | 14700 | EUDAMEDFDA UDI | Class IIa | Active |
| Silginat Refill pack | 14713 | EUDAMEDFDA UDI | Class IIa | Active |
| VSXE One Refill pack | 14782 | EUDAMED | Class IIa | Active |
| Mucopren | 15676 | EUDAMED | Class IIa | Active |
| Identium Heavy, Medium, Medium Soft, Light | K092867 | FDA 510(k) | Class II | Active |
| 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) | K250267 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| 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) | K230333 | FDA 510(k) | Class II | Active |
| Panasil Initial Contact And Panasil Tray | K083701 | FDA 510(k) | Class II | Active |
| Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase And Contact | K082560 | FDA 510(k) | Class II | Active |
| Kingscross Pl-C+b-10, Kingscross Pl-C+b-12, Kingscross Pl-C+b-08, Kingscross B | K122039 | FDA 510(k) | Class II | Active |
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