Question 1

What type of medical products does Adentatec GmbH manufacture?

Accepted Answer

Adentatec GmbH specializes in the production of dental casting non-noble alloys. Their product portfolio consists of various system blanks, including the System Soft-Blank and System Ti5-Blank series, which are manufactured in a range of specific dimensions to meet clinical needs.

Question 2

Where is Adentatec GmbH based?

Accepted Answer

Adentatec GmbH is based in the United States. This location information is provided based on the company's official registration details associated with their medical device operations.

Question 3

How are the devices from Adentatec GmbH classified?

Accepted Answer

The dental devices produced by Adentatec GmbH are classified as Class II medical devices. This classification is determined by regulatory standards for medical equipment, reflecting the risk profile and regulatory requirements associated with these specific dental casting alloys.

Question 4

Which registries list the devices manufactured by Adentatec GmbH?

Accepted Answer

The devices manufactured by Adentatec GmbH are listed in the FDA UDI database. This registry is used to track medical devices throughout their distribution and use, ensuring that the specific products, such as the System Soft-Blank and System Ti5-Blank series, are properly documented.

Device	Model / Reference	Registries	Class	Status
System Soft-Blank 98, 3 x 12 mm	2012-D	FDA UDI	Class II	Active
System Soft-Blank 99, 5 x 12 mm	3012	FDA UDI	Class II	Active
System Soft-Blank 98, 3 x 16 mm	2016	FDA UDI	Class II	Active
System Soft-Blank 99, 5 x 16 mm	3016	FDA UDI	Class II	Active
System Ti5-Blank 99, 5 x 10 mm	6010	FDA UDI	Class II	Active
System Ti5-Blank 99, 5 x 8 mm	6008	FDA UDI	Class II	Active
System Ti5-Blank 98, 5 x 10 mm	7010-T	FDA UDI	Class II	Active
System Soft-Blank 99, 5 x 10 mm	3010-D	FDA UDI	Class II	Active
System Ti5-Blank 98, 5 x 15 mm	7015-T	FDA UDI	Class II	Active
System Soft-Blank 98, 3 x 15 mm	2015-D	FDA UDI	Class II	Active
System Ti5-Blank 98, 5 x 16 mm	7016	FDA UDI	Class II	Active
System Soft-Blank 99, 5 x 8 mm	3008-D	FDA UDI	Class II	Active
System Soft-Blank 98, 3 x 8 mm	2008	FDA UDI	Class II	Active
System Duro	2005002	FDA UDI	Class II	Active
System Soft-Blank 99, 5 x 14 mm	3014-D	FDA UDI	Class II	Active
System Ti5-Blank 99, 5 x 14 mm	6014	FDA UDI	Class II	Active
System Ti5-Blank 98, 5 x 27 mm	7027-T	FDA UDI	Class II	Active
System Soft-Blank 98, 3 x 24, 5 mm	2024-D	FDA UDI	Class II	Active
System NH	2005017	FDA UDI	Class II	Active
System Ti5-Blank 98, 5 x 10 mm	7010	FDA UDI	Class II	Active
System Soft-Blank 98, 3 x 8 mm	2008-D	FDA UDI	Class II	Active
System Ti5-Blank 98, 5 x 15 mm	7015	FDA UDI	Class II	Active
System Soft-Blank 99, 5 x 16 mm	3016-D	FDA UDI	Class II	Active
System Ti5-Blank 98, 5 x 20 mm	7020-T	FDA UDI	Class II	Active
System Ti5-Blank 98, 5 x 8 mm	7008	FDA UDI	Class II	Active
System Ti5-Blank 98, 5 x 16 mm	7016-T	FDA UDI	Class II	Active
System NE	2005009	FDA UDI	Class II	Active
System Soft-Blank 98, 3 x 12 mm	2012	FDA UDI	Class II	Active
System Ti5-Blank 99, 5 x 15 mm	6015-T	FDA UDI	Class II	Active
System Ti5-Blank 99, 5 x 14 mm	6014-T	FDA UDI	Class II	Active
System Ti5-Blank 99, 5 x 16 mm	6016-T	FDA UDI	Class II	Active
System Ti5-Blank 99, 5 x 15 mm	6015	FDA UDI	Class II	Active
System NE-Blank 98, 0 x 10 mm	4010	FDA UDI	Class II	Active
System Ti5-Blank 99, 5 x 27 mm	6027	FDA UDI	Class II	Active
System Soft-Blank 99, 5 x 8 mm	3008	FDA UDI	Class II	Active
System Soft-Blank 99, 5 x 15 mm	3015	FDA UDI	Class II	Active
System Soft-Blank 99, 5 x 20 mm	3020	FDA UDI	Class II	Active
System Soft-Blank 98, 3 x 16 mm	2016-D	FDA UDI	Class II	Active
System Soft-Blank 99, 5 x 18 mm	3018	FDA UDI	Class II	Active

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