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
GQ Quattro Disc NEM Soft 12 mm Ø 98, 5 mit Nut	7802 / 90506512	EUDAMED	Class IIa	Active
Blue Glanz +	706777	EUDAMED	Class IIa	Active
WHITE NEM EASY Disc 13, 5 mm	31909814	EUDAMED	Class IIa	Active
Blue Nem +	701110	EUDAMED	Class IIa	Active
DENTONEM 98x13, 5mm	22.000.C13	EUDAMED	Class IIa	Active
CoCrMo6 Fraesrohling 98, 5x25mm	2570200250	EUDAMED	Class IIa	Active
Denseo NEM Blank	26018	EUDAMED	Class IIa	Active
dima Mill CoCr solid 99x16	66097760	EUDAMED	Class IIa	Active
DENTONEM 98x12mm	22.000.C12	EUDAMED	Class IIa	Active
AGC® Goldbad Comfort	77-00-3014	EUDAMED	Class IIa	Active
dima Mill CoCr solid 99x20	66070828	EUDAMED	Class IIa	Active
Blue Classic +	706007	EUDAMED	Class IIa	Active
AGC® Goldbad Speed	77-00-1007	EUDAMED	Class IIa	Active
AGC® Glanzzusatz	77-40-1004	EUDAMED	Class IIa	Active
Tizian Blank NEM fine 98 x 14 mm	220279	EUDAMED	Class IIa	Active
dima Mill CoCr solid 99x10	66069997	EUDAMED	Class IIa	Active
Tizian Blank NEM fine 98 x 15 mm	220295	EUDAMED	Class IIa	Active
Disque de chrome cobalt 13, 5 mm	2570300135	EUDAMED	Class IIa	Active
Disque de chrome cobalt 15 mm	2570300150	EUDAMED	Class IIa	Active
dima Mill CoCr solid 99x15	66070000	EUDAMED	Class IIa	Active
dima Mill CoCr solid 99x18	66070001	EUDAMED	Class IIa	Active
balance Glanzzusatz	AG0000000767	EUDAMED	Class IIa	Active
Denseo NEM Blank	26013	EUDAMED	Class IIa	Active
GQ Glanzzusatz	30301530	EUDAMED	Class IIa	Active
Denseo NEM Blank	25017	EUDAMED	Class IIa	Active
GQ Quattro Disc NEM Soft 15 mm Ø 98, 5 mit Nut	7804 / 90506514	EUDAMED	Class IIa	Active
DENTONEM 98x18mm	22.000.C18	EUDAMED	Class IIa	Active
CoCrMo6 Fraesrohling 98, 5x14mm	2570200140	EUDAMED	Class IIa	Active
NEM/CoCr Blank	3031	EUDAMED	Class IIa	Active
Zfx™ Cobalt Chromium Eco 98x20	ZFX08000820	EUDAMED	Class IIa	Active
dima Mill CoCr solid 99x13.5	66069999	EUDAMED	Class IIa	Active
Galvano Standard	40010	EUDAMED	Class IIa	Active
Tizian Blank NEM fine 98 x 8 mm	220291	EUDAMED	Class IIa	Active
Zfx™ Cobalt Chromium Eco 98x15	ZFX08000815	EUDAMED	Class IIa	Active
GQ Quattro Disc NEM Soft 13, 5 mm Ø 98, 5 mit Nut	7803 / 90506513	EUDAMED	Class IIa	Active
CoCrMo6 Fraesrohling 98, 5x10mm	2570200100	EUDAMED	Class IIa	Active
DENTONEM 98x20mm	22.000.C20	EUDAMED	Class IIa	Active
Tizian Blank NEM fine 98 x 18 mm	220296	EUDAMED	Class IIa	Active
optimill acero	14240	EUDAMED	Class IIa	Active
Denseo NEM Blank	26015	EUDAMED	Class IIa	Active
optimill acero	14234	EUDAMED	Class IIa	Active
Tizian Blank NEM fine 98 x 12 mm	220293	EUDAMED	Class IIa	Active
optimill acero	14233	EUDAMED	Class IIa	Active
balance Härtezusatz	AG0000000765	EUDAMED	Class IIa	Active
Blue Extra +	701001	EUDAMED	Class IIa	Active
Denseo NEM Blank	26012	EUDAMED	Class IIa	Active
CoCrMo6 Fraesrohling 98, 5x18mm	2570200180	EUDAMED	Class IIa	Active
WHITE NEM EASY Disc 10 mm	31909810	EUDAMED	Class IIa	Active
AGC® Goldbad 5 Process	77-00-1004	EUDAMED	Class IIa	Active
Galvano NEO	40014	EUDAMED	Class IIa	Active

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