Question 1

What types of medical devices does Zhermack SpA manufacture?

Accepted Answer

Zhermack SpA specializes in dental impression materials and related tools. Their portfolio includes silicone-based dental impression materials like neocolloid, alginate-based materials such as Freealgin and Elite HD+ series (including Regular Body, Putty Soft, and Maxi Tray variants), and specialized mixing nozzles and tips. These products are designed for precise application in dental procedures, ensuring accurate impressions for restorations or diagnostics.

Question 2

Where is Zhermack SpA based, and what does this mean for their devices?

Accepted Answer

Zhermack SpA operates from the United States, which means their devices must comply with U.S. regulatory requirements, including those set by the FDA. This includes classification under FDA’s device categories and, where applicable, listing in the FDA’s Unique Device Identifier (UDI) database. Compliance ensures their products meet safety, performance, and quality standards for use in dental practices.

Question 3

Which regulatory registries list Zhermack SpA’s devices?

Accepted Answer

Zhermack SpA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system provides a standardized way to identify medical devices, ensuring traceability and transparency in regulatory oversight. Listing in this database is a requirement for Class I and Class II devices, which Zhermack’s dental impression materials and mixing tools fall under.

Question 4

How are Zhermack SpA’s devices classified by the FDA?

Accepted Answer

Zhermack SpA’s devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional controls to ensure their safety and effectiveness. Dental impression materials and mixing tools are typically classified this way due to their role in diagnostic or restorative procedures, where precision and reliability are critical but risks are manageable with proper regulatory oversight.

Question 5

Why do Zhermack SpA’s mixing nozzles and tips matter in dental procedures?

Accepted Answer

Zhermack SpA’s mixing nozzles and tips, including dynamic-static mixing tips, are engineered to ensure consistent and precise blending of dental impression materials. Proper mixing is essential for achieving accurate impressions, as inconsistencies can lead to flawed restorations or diagnostics. These tools help dental professionals maintain uniformity in material properties, which directly impacts the quality and reliability of the final dental work.

Device	Model / Reference	Registries	Class	Status
Acrytemp CB A2	C700200	FDA UDI	Class II	Unknown
Elite HD+ Putty Soft Fast Set	C203012	FDA UDI	Class II	Active
hydrogum 5	C302072	FDA UDI	Class II	Unknown
Elite HD+ Maxi Monophase Normal Set	C202300	FDA UDI	Class II	Unknown
Occlufast Rock	C200726	FDA UDI	Class II	Active
Elite HD+ Putty Soft Normal Set	C203002	FDA UDI	Class II	Active
Elite HD+ Monophase Normal Set	C202020	FDA UDI	Class II	Active
Mixing Tips	C205500	FDA UDI	Class I	Unknown
Elite HD+ Light Body Normal Set	C203030	FDA UDI	Class II	Active
hydrogum	C302025	FDA UDI	Class II	Active
Mixing Tips	C202090	FDA UDI	Class I	Active
orthoprint	C302145	FDA UDI	Class II	Active
Freealgin Maxi	C300102	FDA UDI	Class II	Unknown
Mixing Tips	C203233	FDA UDI	Class I	Unknown

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