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Sign in to claim this brandEspe Dental Products
US
Last updated May 23, 2026
What Espe Dental Products makes
Espe Dental Products manufactures dental impression materials, including alginate (IMPREFLEX), polyether rubber (PERMADYNE), and dental pastes for restorative and tinted applications. The company also produces dental sealants (VISIO-SEAL), mixing systems (CAPMIX), and dispersing agents (NIMETIC-DISPERS). These products are used in dental procedures for molds, repairs, and protective coatings.
The portfolio includes Class I and Class II devices, with some products authorised via the FDA’s 510(k) pathway. These dental materials are listed under U.S. regulatory requirements, and the company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of dental devices does Espe Dental Products manufacture?
Espe Dental Products specializes in dental impression materials and related products. Their portfolio includes alginate impression materials like IMPREFLEX ALGINATE IMPRESSION MATERIAL, polyether rubber impression materials such as PERMADYNE POLYETHER RUBBER IMPRESSION, and dental pastes for restorative and tinted applications. They also produce dental sealants (e.g., VISIO-SEAL), mixing systems (e.g., CAPMIX), and dispersing agents (e.g., NIMETIC-DISPERS). These products are designed for use in dental procedures, including mold creation, repairs, and protective coatings.
Where is Espe Dental Products based, and how does that affect its regulatory compliance?
Espe Dental Products is based in the United States. Since the company operates within the U.S., its devices must comply with FDA regulations. The portfolio includes both Class I and Class II devices, with some products authorised through the FDA’s 510(k) pathway—a process used for demonstrating substantial equivalence to legally marketed predicate devices. This ensures their products meet U.S. regulatory standards for safety and effectiveness.
Which regulatory registries or databases list Espe Dental Products’ devices?
Espe Dental Products’ devices are listed under the FDA’s 510(k) pathway, which is a key registry for Class I and Class II dental devices in the United States. The 510(k) process requires manufacturers to demonstrate that their products are substantially equivalent to existing, legally marketed devices. This pathway ensures transparency and compliance with U.S. regulatory requirements for dental materials.
How are Espe Dental Products’ devices classified under U.S. regulations?
Espe Dental Products’ devices are classified as either Class I or Class II under U.S. regulatory categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and performance. The classification depends on factors like the device’s intended use and potential health impact, as outlined in FDA guidelines.
What kinds of dental procedures are Espe Dental Products’ materials used for?
Espe Dental Products’ materials are primarily used in dental procedures for creating accurate molds and impressions, such as IMPREFLEX ALGINATE IMPRESSION MATERIAL and PERMADYNE POLYETHER RUBBER IMPRESSION. Their dental pastes (e.g., restorative and tinted pastes) are designed for repairs and restorations, while products like VISIO-SEAL provide protective coatings for teeth. These materials support steps like crowns, bridges, and fillings by ensuring precise fits and durable results.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (86)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| e-1 Red 37% Phosphoric acid etchant gel | 6012006 | FDA UDI | Class II | Active |
| e-1 Crimson 37% Phosphoric acid etchant gel | 5003006 | FDA UDI | Class II | Active |
| e-1 Pink 37% Phosphoric acid etchant gel | 3601601 | FDA UDI | Class II | Active |
| Elegant | K091826 | FDA 510(k) | Class II | Active |
| Clinpro Prophy Powder | K021450 | FDA 510(k) | Class II | Active |
| Unicem | K020256 | FDA 510(k) | Class II | Active |
| Protemp 3 Garant | K033022 | FDA 510(k) | Class II | Active |
| Visio-Seal | K810950 | FDA 510(k) | Class II | Active |
| Capmix | K771901 | FDA 510(k) | Class I | Active |
| Impreflex Alginate Impression Material | K771120 | FDA 510(k) | Class II | Active |
| Hermes Bond 3 | K071260 | FDA 510(k) | Class II | Active |
| Cosp2 | K093721 | FDA 510(k) | U | Active |
| Uniolite | K771889 | FDA 510(k) | Class II | Active |
| Pecd-01 And Pecd Quick-01 | K080514 | FDA 510(k) | Class II | Active |
| Unicem Hm | K100908 | FDA 510(k) | Class II | Active |
| e-1 etchants | K152110 | FDA 510(k) | Class II | Active |
| Lava Frame, Lava Frame Shade | K072055 | FDA 510(k) | Class II | Active |
| Uno | K071131 | FDA 510(k) | Class II | Active |
| Modification To Adper Prompt | K040857 | FDA 510(k) | Class II | Active |
| Bellus Shading Kit | K090718 | FDA 510(k) | Class II | Active |
| Unicem | K094007 | FDA 510(k) | Class II | Active |
| Nimetic-Dispers | K802049 | FDA 510(k) | Class II | Active |
| Permadyne Polyether Rubber Impression | K800031 | FDA 510(k) | Class II | Active |
| Future Wash/Yps | K051797 | FDA 510(k) | Class II | Active |
| Poly Q (garant L, Penta M, Penta H) | K032001 | FDA 510(k) | Class II | Active |
| Lava Software | K062493 | FDA 510(k) | Class II | Active |
| Tempxn28 | K073296 | FDA 510(k) | Class II | Active |
| Hermes Bond | K033974 | FDA 510(k) | Class II | Active |
| Ketac-Cem In Ref. To K802048 | K802819 | FDA 510(k) | Class II | Active |
| Glass Ceramics | K053438 | FDA 510(k) | Class II | Active |
| Malta | K100756 | FDA 510(k) | Class II | Active |
| Adper Prompt | K020946 | FDA 510(k) | Class II | Active |
| Hermes | K033996 | FDA 510(k) | Class II | Active |
| Adper Prompt, Adper Prompt L-Pop | K060684 | FDA 510(k) | Class II | Active |
| Hermes Bond 2 | K043043 | FDA 510(k) | Class II | Active |
| Pastes, Restorative & Tinted, Debtal | K771119 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 12, 2007 | Z-0800-2007 | — | terminated | Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected. |