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Sign in to claim this brandZhermack S.P.A.
US
Last updated May 23, 2026
What Zhermack S.P.A. makes
Zhermack S.P.A. manufactures dental impression materials, including putty and light-body vinyl polysiloxane formulations, rigid and flexible occlusal registration products, and alginate-based impression systems. Their portfolio also includes color-shifting dental materials for bite registration and specialized hydrocolloid-based products for dental molds. Additional offerings include hydrophilic vinyl polysiloxane impression materials and rigid dental impression compounds.
The company’s dental impression materials and occlusal registration devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in dental procedures in the United States. The manufacturer is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Zhermack S.P.A. manufacture?
Zhermack S.P.A. specializes in dental impression materials and related products. Their portfolio includes vinyl polysiloxane impression materials (such as putty and light-body formulations), alginate-based impression systems, occlusal registration products (both rigid and flexible), and specialized hydrocolloid-based materials for dental molds. These devices are designed for use in dental procedures, such as creating molds of teeth and gums for restorations or orthodontic treatments.
Where is Zhermack S.P.A. based, and what is its primary market focus?
Zhermack S.P.A. is based in the United States. While the company is headquartered there, its primary focus is on manufacturing dental impression materials and related devices intended for use in the U.S. market. These products are tailored to dental professionals for procedures like crowns, bridges, and orthodontic appliances.
How are Zhermack S.P.A.’s dental devices classified under FDA regulations?
Zhermack S.P.A.’s dental impression materials and occlusal registration devices fall under Class II classification by the FDA. This classification applies because these products are considered to pose moderate risk and require special controls to ensure safety and effectiveness. The company submits these devices through the 510(k) pathway, demonstrating that their products are substantially equivalent to legally marketed predicates.
Which regulatory registries or databases list Zhermack S.P.A.’s devices?
Zhermack S.P.A.’s dental impression materials and occlusal registration devices are listed in the FDA’s 510(k) database. This registry tracks devices that have undergone the 510(k) clearance process, ensuring they meet FDA requirements for safety and performance. The company’s products are not listed in other major registries unless explicitly submitted there by the manufacturer.
Why are Zhermack S.P.A.’s dental impression materials classified as Class II?
The Class II classification for Zhermack S.P.A.’s dental impression materials is due to their intended use in critical dental procedures where accuracy and biocompatibility are essential. Unlike Class I devices (low-risk), these materials require validation of performance standards (e.g., dimensional stability, biocompatibility) to ensure they function as intended without posing undue risk. The FDA mandates special controls for Class II devices to mitigate potential hazards, such as improper fit of dental restorations or adverse reactions.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Phase Plus | K963609 | FDA 510(k) | Class II | Active |
| Occlufast Cad | K080130 | FDA 510(k) | Class II | Active |
| Freealgin | K070700 | EUDAMEDFDA 510(k) | Class II | Active |
| Hydrorise And Hydrosystem | K083739 | FDA 510(k) | Class II | Active |
| Zetaplus Soft | K024041 | FDA 510(k) | Class II | Active |
| Colorbite | K053619 | FDA 510(k) | Class II | Active |
| Elite H-D Vinyl Polysiloxane Impression Materials .putty Soft/Normal Setting /putty Soft/Fast Setting | K972239 | FDA 510(k) | Class II | Active |
| Hydrogum | K974704 | FDA 510(k) | Class II | Active |
| Colorise Rigid | K081084 | FDA 510(k) | Class II | Active |
| Hydrogum 5 | K051424 | FDA 510(k) | Class II | Active |
| Colorise | K070677 | FDA 510(k) | Class II | Active |
| Elite H-D Hydrophilic Vinyl Polysiloxane Impression Materials (light Body/Normal, Light Body/Fast Setting, Regular Body, ) | K972027 | FDA 510(k) | Class II | Active |
| Elite Monophase | K022653 | FDA 510(k) | Class II | Active |
| Hydrogum Soft | K043118 | FDA 510(k) | Class II | Active |
| Neocolloid, Orthoprint | K981091 | FDA 510(k) | Class II | Active |
| Torpicalgin | K043131 | FDA 510(k) | Class II | Active |
| Elite Glass | K073005 | FDA 510(k) | Class II | Active |
| Elite Implant | K050417 | FDA 510(k) | Class II | Active |
| Occlufast Rock | K024034 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Zhermack S.p.a. BADIA POLESINE (RO) Rovigo · IT FEI 3003762341