Question 1

What types of medical devices does C.HAFNER GmbH + Co. KG manufacture?

Accepted Answer

C.HAFNER GmbH + Co. KG specializes in dental casting alloys and related materials used in dental restorations. Their portfolio includes gold-based alloys like Orplid H and Pangold LFC, ceramic-fused-to-metal frameworks such as Pangold Keramik N2, welding wires (e.g., Orplid GK and Orplid LFC), and activators for dental hardening processes (e.g., AGC Härte and AGC NEM series). These products are designed for both machined and cast dental components, primarily for crowns, bridges, and other restorative applications.

Question 2

Where is C.HAFNER GmbH + Co. KG based, and what does that mean for its regulatory compliance?

Accepted Answer

C.HAFNER GmbH + Co. KG is based in Germany, which places its devices under the jurisdiction of the European Union’s medical device regulations. Since the company manufactures dental casting alloys and related products, these fall under the EU’s medical device framework, ensuring compliance with EU-wide standards for safety, performance, and traceability. The fact that its devices are listed in the eudamed registry reflects this adherence to EU regulatory requirements.

Question 3

Which EU medical device registries list C.HAFNER’s products, and why is this important?

Accepted Answer

C.HAFNER’s dental casting alloys and related devices are listed in the eudamed registry, the official EU database for medical devices. This registry is critical because it provides transparency on device manufacturers, their products, and regulatory status within the EU. Listing in eudamed ensures that healthcare professionals, regulators, and authorities can verify the manufacturer’s identity and the classification of their devices, which is particularly important for Class IIa products like those offered by C.HAFNER.

Question 4

How are C.HAFNER’s dental casting alloys classified under EU medical device regulations?

Accepted Answer

C.HAFNER’s dental casting alloys and related products are classified as Class IIa medical devices under EU regulations. This classification is determined based on factors such as the intended use, potential risks, and the body’s interaction with the device. Class IIa devices are considered to have a moderate risk and require compliance with specific EU directives, including design controls, clinical evaluations, and post-market surveillance, to ensure their safety and performance in dental applications.

Device	Model / Reference	Registries	Class	Status
Orplid Lot 790	1069	EUDAMED	Class IIa	Active
Cehadent Plus, Guss	1586	EUDAMED	Class IIa	Active
Helioform H Konzentrat	7351	EUDAMED	Class IIa	Active
Pangold Keramik N2, Guss	1054	EUDAMED	Class IIa	Active
Orplid Keramik 4, Schweißdraht 0, 35 mm	1189	EUDAMED	Class IIa	Active
Pangold LFC, Guss	1596	EUDAMED	Class IIa	Active
Cehadentor 2, Schweißdraht 0, 35 mm	1249	EUDAMED	Class IIa	Active
Orplid Keramik 3, Guss	1027	EUDAMED	Class IIa	Active
CeHa LIGHT CLASSIC, Guss	1532	EUDAMED	Class IIa	Active
Orplid C, Schweißdraht 0, 35 mm	1440	EUDAMED	Class IIa	Active
Orplid Keramik 21, Guss	1521	EUDAMED	Class IIa	Active
Orplid C, Guss	1409	EUDAMED	Class IIa	Active
Interpal SE, Guss	1563	EUDAMED	Class IIa	Active
Orplid Keramik 3, gefräst	1572	EUDAMED	Class IIa	Active
Orplid EH, Schweißdraht 0, 35 mm	1242	EUDAMED	Class IIa	Active
Orplid Inlay, Guss	1274	EUDAMED	Class IIa	Active
Universal Schweißdraht Classic 0, 35 mm	1549	EUDAMED	Class IIa	Active
Orplid Keramik 5, gefräst	1569	EUDAMED	Class IIa	Active
AURUMED Bio SGG	46094	EUDAMED	Class IIa	Active
Orplid GK, Guss	1033	EUDAMED	Class IIa	Active
Orplid H, Schweißdraht 0, 35 mm	1187	EUDAMED	Class IIa	Active
AGC Glanzzusatz	8521	EUDAMED	Class IIa	Active
Orplid Keramik 5, Guss	1275	EUDAMED	Class IIa	Active
AURUMED Bio Safir, Schweißdraht 0, 35 mm	1601	EUDAMED	Class IIa	Active
AURUMED Eco 38	43077	EUDAMED	Class IIa	Active
Orplid Keramik 5, Schweißdraht 0, 35 mm	1280	EUDAMED	Class IIa	Active
Biorplid G2, Schweißdraht 0, 35 mm	1568	EUDAMED	Class IIa	Active
Orplid H, Guss	1026	EUDAMED	Class IIa	Active
Eco 52, Guss	1589	EUDAMED	Class IIa	Active
AGC Micro Vision Goldbad	8540	EUDAMED	Class IIa	Active
Orplid Lot 825	1068	EUDAMED	Class IIa	Active
Orplid GK, gefräst	1577	EUDAMED	Class IIa	Active
AURUMED Norm	65089	EUDAMED	Class IIa	Active
Unilight Plus, Guss	1545	EUDAMED	Class IIa	Active
Cehadentor Keramik SF3, Guss	1032	EUDAMED	Class IIa	Active
AURUMED Gold Plus	59299	EUDAMED	Class IIa	Active
Cehadentor 2, Guss	1016	EUDAMED	Class IIa	Active
Biorplid G1, Schweißdraht 0, 35 mm	1580	EUDAMED	Class IIa	Active
Orplid Implant, Schweißdraht 0, 35 mm	1511	EUDAMED	Class IIa	Active
Biorplid Keramik, Guss	1028	EUDAMED	Class IIa	Active
AGC Micro Goldbad	8539	EUDAMED	Class IIa	Active
Biorplid Keramik, Schweißdraht 0, 35 mm	1248	EUDAMED	Class IIa	Active
Eco 52, Schweißdraht 0, 35 mm	1593	EUDAMED	Class IIa	Active
Orplid TK, Schweißdraht 0, 35 mm	1576	EUDAMED	Class IIa	Active
AURUMED Bio Safir	43540	EUDAMED	Class IIa	Active
Aurumed Kf 55	46093	EUDAMED	Class IIa	Active
Orplid CF, gedruckt	1605	EUDAMED	Class IIa	Active
Orplid Universal, Schweißdraht 0, 35 mm	1515	EUDAMED	Class IIa	Active
Orplid Keramik PF, Guss	1030	EUDAMED	Class IIa	Active
Helioform H Elektrolyt	8281	EUDAMED	Class IIa	Active

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