Question 1

What types of medical devices does WIELAND Edelmetalle GmbH manufacture?

Accepted Answer

WIELAND Edelmetalle GmbH specialises in dental medical devices, including titanium alloy implants and components like the GQ Quattro Disc, WHITE NEM EASY Disc, and DENTONEM. They also produce cobalt-chromium milling blanks (e.g., CoCrMo6 and dima Mill CoCr solid) for dental restorations, as well as gold baths (e.g., AGC® Goldbad Comfort) used in dental laboratory processes. These products are designed for dental applications requiring high precision and biocompatibility.

Question 2

Where is WIELAND Edelmetalle GmbH based, and what does this mean for its regulatory compliance?

Accepted Answer

WIELAND Edelmetalle GmbH is based in Germany, which means its devices are subject to EU medical device regulations. Since these products fall under EU Class IIa classification, they must comply with the EU Medical Device Regulation (MDR) or the previous Medical Device Directive (MDD), depending on their conformity date. The company’s devices are registered in the EU’s eudamed database, ensuring transparency and traceability within the European market.

Question 3

Which regulatory registries list WIELAND Edelmetalle GmbH’s devices?

Accepted Answer

WIELAND Edelmetalle GmbH’s devices are listed in the eudamed database, the official EU registry for medical devices. This registry is maintained under the EU Medical Device Regulation (MDR) and allows healthcare professionals, authorities, and patients to verify the legitimacy and compliance status of Class IIa devices marketed in the European Union.

Question 4

How are WIELAND Edelmetalle GmbH’s devices classified under EU regulations?

Accepted Answer

WIELAND Edelmetalle GmbH’s devices are classified as EU Class IIa medical devices. This classification is determined based on their intended use and risk level—dental implants and related components fall into this category due to their moderate risk profile, requiring compliance with specific EU safety, performance, and clinical evaluation requirements before market placement.

Device	Model / Reference	Registries	Class	Status
Galvano NEO	40014	EUDAMED	Class IIa	Active
AGC® Glanzzusatz Comfort	77-40-1009	EUDAMED	Class IIa	Active
DENTONEM 98x8mm	22.000.C08	EUDAMED	Class IIa	Active
dima Mill CoCr solid 99x8	66070827	EUDAMED	Class IIa	Active
DENTONEM 98x15mm	22.000.C15	EUDAMED	Class IIa	Active
AGC® Glanzzusatz Multi Color	77-40-1018	EUDAMED	Class IIa	Active
Zfx™ Cobalt Chromium Eco 98x18	ZFX08000818	EUDAMED	Class IIa	Active
AGC® Härte Aktivator	77-40-1015	EUDAMED	Class IIa	Active
balance Galvanobad 16, 6	AG3000000761	EUDAMED	Class IIa	Active
GQ NEM-Aktivator	30301531	EUDAMED	Class IIa	Active
CoCrMo6 Fraesrohling 98, 5x13, 5mm	2570200135	EUDAMED	Class IIa	Active
GQ Quattro Disc NEM Soft 10 mm Ø 98, 5	7801 / 90506511	EUDAMED	Class IIa	Active
GQ Quattro Disc NEM Soft 8 mm Ø 98, 5	7800 / 90506510	EUDAMED	Class IIa	Active
BLUE EXTRA + Mini	701011	EUDAMED	Class IIa	Active
CoCrMo6 Fraesrohling 98, 5x20mm	2570200200	EUDAMED	Class IIa	Active
NEM/CoCr Blank	3035	EUDAMED	Class IIa	Active
WHITE NEM EASY Disc 20 mm mit Nut	30909820	EUDAMED	Class IIa	Active
WHITE NEM EASY Disc 13, 5 mm mit Nut	30909813	EUDAMED	Class IIa	Active
optimill acero	14232	EUDAMED	Class IIa	Active
Tizian Blank NEM fine 98 x 13, 5 mm	220294	EUDAMED	Class IIa	Active
WHITE NEM EASY Disc 15 mm mit Nut	30909815	EUDAMED	Class IIa	Active
GQ Galva M	60101550	EUDAMED	Class IIa	Active
AGC® NEM Aktivator	77-40-1010	EUDAMED	Class IIa	Active
CoCrMo6 Fraesrohling 98, 5x16mm mit Nut	2570300160	EUDAMED	Class IIa	Active
Denseo NEM Blank	25018	EUDAMED	Class IIa	Active
WHITE NEM EASY Disc 18 mm	31909818	EUDAMED	Class IIa	Active
GQ Härtezusatz	30301532	EUDAMED	Class IIa	Active
Denseo NEM Blank	25015	EUDAMED	Class IIa	Active
Disque de chrome cobalt 8 mm	2570200080	EUDAMED	Class IIa	Active
CoCrMo6 Fraesrohling 98, 5x25mm mit Nut	2570300250	EUDAMED	Class IIa	Active
CoCrMo6 Fraesrohling 98, 5x12mm	2570200120	EUDAMED	Class IIa	Active
DENTONEM 98x10mm	22.000.C10	EUDAMED	Class IIa	Active
dima Mill CoCr solid 99x25	66097761	EUDAMED	Class IIa	Active
Tizian Blank NEM fine 98 x 20 mm	220297	EUDAMED	Class IIa	Active
optimill acero	14241	EUDAMED	Class IIa	Active
Zfx™ Cobalt Chromium Eco 98x10	ZFX08000810	EUDAMED	Class IIa	Active
CoCrMo6 Fraesrohling 98, 5x15mm mit Nut	2570300150	EUDAMED	Class IIa	Active
balance NEM-Aktivator	AG0000000766	EUDAMED	Class IIa	Active
WHITE NEM EASY Disc 12 mm mit Nut	30909812	EUDAMED	Class IIa	Active
optimill acero	14242	EUDAMED	Class IIa	Active
dima Mill CoCr solid 99x12	66069998	EUDAMED	Class IIa	Active
CoCrMo6 Fraesrohling 98, 5x8mm	2570200080	EUDAMED	Class IIa	Active
CoCrMo6 Fraesrohling 98, 5x13, 5mm mit Nut	2570300135	EUDAMED	Class IIa	Active
NEM/CoCr Blank	3034	EUDAMED	Class IIa	Active
NEM-Aktivator	40016	EUDAMED	Class IIa	Active
GQ Quattro Disc NEM Soft 20 mm Ø 98, 5 mit Nut	7810 / 90506516	EUDAMED	Class IIa	Active
CoCrMo6 Fraesrohling	2570300140	EUDAMED	Class IIa	Active
Disque de chrome cobalt 18 mm	2570300180	EUDAMED	Class IIa	Active
Glanzzusatz	40012	EUDAMED	Class IIa	Active
Denseo NEM Blank	25013	EUDAMED	Class IIa	Active

WIELAND Edelmetalle GmbH

About

What WIELAND Edelmetalle GmbH makes

Frequently asked questions

Information

Catalogue (124)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)