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
hydrogum soft	C302060	FDA UDI	Class II	Unknown
hydrogum 5	SP50050	FDA UDI	Class II	Unknown
Colorbite D	C200750	FDA UDI	Class II	Unknown
thixoflex M	C100670	FDA UDI	Class II	Unknown
tropicalgin	C302241	FDA UDI	Class II	Unknown
neocolloid	C302205	FDA UDI	Class II	Active
Elite HD+ Maxi Monophase Normal Set	C202310	FDA UDI	Class II	Unknown
Elite HD+ Regular Body Normal Set	C203020	FDA UDI	Class II	Active
Mixing Tips	C202070	FDA UDI	Class I	Active
Elite HD+ Putty Soft Normal Set	C203000	FDA UDI	Class II	Active
Acrytemp CB A3	C700215	FDA UDI	Class II	Unknown
orthoprint	SP50053	FDA UDI	Class II	Unknown
Freealgin	C300110	FDA UDI	Class II	Active
tropicalgin	C302245	FDA UDI	Class II	Unknown
Elite HD+ Maxi Tray Material Fast Set	C202320	FDA UDI	Class II	Active
orthoprint	C302160	FDA UDI	Class II	Unknown
Elite Glass	C401610	FDA UDI	Class II	Active
zetaplus	C100600	FDA UDI	Class II	Unknown
Mixing Tips	C202080	FDA UDI	Class I	Active
hydrogum 5	SP50051	FDA UDI	Class II	Unknown
Mixing Tips	C202086	FDA UDI	Class I	Active
Dynamic-static Mixing Tips	C205530	FDA UDI	Class I	Active
hydrogum 5	SP50052	FDA UDI	Class II	Unknown
Mixing Tips	C202086	FDA UDI	Class I	Active
Mixing tips 4:1	C700240	FDA UDI	Class I	Unknown
Dynamic-static Mixing Tips	C205530	FDA UDI	Class I	Active
Elite HD+ Light Body Normal Set	C203035	FDA UDI	Class II	Unknown
Elite HD+ Light Body Fast Set	C203040	FDA UDI	Class II	Active
hydrogum 5	C302071	FDA UDI	Class II	Unknown
Mixing Tips	C202085	FDA UDI	Class I	Active
hydrogum 5	C302075	FDA UDI	Class II	Active
orthoprint	C302171	FDA UDI	Class II	Unknown
Mixing Tips	C202085	FDA UDI	Class I	Active
hydrogum 5	C302070	FDA UDI	Class II	Active
Freealgin Maxi	C300100	FDA UDI	Class II	Unknown
Occlufast Cad	C200800	FDA UDI	Class II	Active
tropicalgin	SP50054	FDA UDI	Class II	Unknown
tropicalgin	C302242	FDA UDI	Class II	Unknown
indurent gel	C100700	FDA UDI	Class II	Unknown
Colorbite Rock	C200760	FDA UDI	Class II	Unknown
tropicalgin	C302240	FDA UDI	Class II	Active
Elite HD+ Maxi Tray Material Fast Set	C202330	EUDAMEDFDA UDI	Class II	Active
Mixing Tips	C202090	FDA UDI	Class I	Active
Elite HD+ Regular Body Normal Set	C203025	FDA UDI	Class II	Active
Elite HD+ Tray Material Fast Set	C202032	FDA UDI	Class II	Active
Elite HD+ Super Light Body Fast Set	C203050	FDA UDI	Class II	Active
Elite HD+ Putty Soft Fast Set	C203010	FDA UDI	Class II	Active
Freealgin Eco Pack	C300112	FDA UDI	Class II	Unknown
Acrytemp CB A 3, 5	C700205	FDA UDI	Class II	Unknown
orthoprint	C302161	FDA UDI	Class II	Unknown

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