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Espe 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

Country
US
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Catalogue (86)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
e-1 Green 37% Phosphoric acid etchant gel 2003006
FDA UDI
Class IIActive
e-1 Orange 37% Phosphoric acid 1010001
FDA UDI
Class IIActive
e-1 Green 37% Phosphoric acid etchant gel 2601601
FDA UDI
Class IIActive
e-1 Crimson 37% Phosphoric acid etchant gel 5602602
FDA UDI
Class IIActive
e-1 Seafoam 37% Phosphoric acid gel etchant 9012144
FDA UDI
Class IIActive
e-1 Purple 37% Phosphoric acid gel etchant 8003006
FDA UDI
Class IIActive
e-1 Purple 37% phosphoric acid gel etchant 8602602
FDA UDI
Class IIActive
e-1 Blue 37% Phosphoric acid etchant gel 4601601
FDA UDI
Class IIActive
e-2 Purple 37% phosphoric acid gel etchant 8012144
FDA UDI
Class IIActive
e-1 Red 37% Phosphoric acid etchant gel 6012024
FDA UDI
Class IIActive
e-1 Blue 37% Phosphoric acid etchant gel 4003006
FDA UDI
Class IIActive
e-1 Orange 37% Phosphoric acid etchant gel 1601601
FDA UDI
Class IIActive
e-1 Pink 37% Phosphoric acid etchant gel 3010001
FDA UDI
Class IIActive
e-1 Seafoam 37% Phosphoric acid gel etchant 9601601
FDA UDI
Class IIActive
e-1 Pink 37% Phosphoric acid etchant gel 3012024
FDA UDI
Class IIActive
e-1 Crimson 37% Phosphoric acid etchant gel 5601601
FDA UDI
Class IIActive
e-1 Pink 37% Phosphoric acid etchant gel 3003006
FDA UDI
Class IIActive
e-1 Multi-color 37% Phosphoric acid etchant gel 7012024
FDA UDI
Class IIActive
e-1 Red 37% Phosphoric acid etchant gel 6010001
FDA UDI
Class IIActive
e-1 Green 37% Phosphoric acid etchant gel 2010001
FDA UDI
Class IIActive
e-1 Multi-color 37% Phosphoric acid etchant gel 7012006
FDA UDI
Class IIActive
e-1 Seafoam 37% Phosphoric acid etchant gel 9602602
FDA UDI
Class IIActive
e-1 Pink 37% Phosphoric acid etchant gel 3012006
FDA UDI
Class IIActive
e-1 Orange 37% Phosphoric acid etchant gel 1003006
FDA UDI
Class IIActive
e-1 Seafoam 37% Phosphoric acid gel etchant 9003006
FDA UDI
Class IIActive
e-1 Pink 37% Phosphoric acid etchant gel 3602602
FDA UDI
Class IIActive
e-1 Crimson 37% Phosphoric acid etchant gel 5012006
FDA UDI
Class IIActive
e-1 Blue 37% Phosphoric acid etchant gel 4012006
FDA UDI
Class IIActive
e-1 Blue 37% Phosphoric acid etchant gel 4012024
FDA UDI
Class IIActive
e-1 Purple 37% Phosphoric acid gel etchant 8012024
FDA UDI
Class IIActive
e-1 Crimson 37% Phosphoric acid etchant gel 5012024
FDA UDI
Class IIActive
e-1 Blue 37% Phosphoric acid etchant gel 4010001
FDA UDI
Class IIActive
e-1 Seafoam 37% Phosphoric acid gel etchant 9012006
FDA UDI
Class IIActive
e-1 Purple 37% phosphoric acid gel etchant 8601601
FDA UDI
Class IIActive
e-1 Crimson 37% Phosphoric acid etchant gel 5010001
FDA UDI
Class IIActive
e-1 Green 37% Phosphoric acid etchant gel 2602602
FDA UDI
Class IIActive
e-1 Green 37% Phosphoric acid etchant gel 2012024
FDA UDI
Class IIActive
e-1 Purple 37% phosphoric acid gel etchant 8012006
FDA UDI
Class IIActive
e-1 Seafoam 37% Phosphoric acid gel etchant 9012024
FDA UDI
Class IIActive
e-1 Orange 37% Phosphoric acid etchant gel 1012006
FDA UDI
Class IIActive
e-1 Blue 37% Phosphoric acid etchant gel 4602602
FDA UDI
Class IIActive
e-1 Orange 37% Phosphoric acid etchant gel 1012024
FDA UDI
Class IIActive
e-1 Red 37% Phosphoric acid etchant gel 6601601
FDA UDI
Class IIActive
e-1 Red 37% Phosphoric acid etchant gel 6003006
FDA UDI
Class IIActive
e-1 Green 37% Phosphoric acid gel etchant 2012006
FDA UDI
Class IIActive
e-1 Multi-color 37% Phosphoric acid etchant gel 7003006
FDA UDI
Class IIActive
e-1 Red 37% Phosphoric acid etchant gel 6602602
FDA UDI
Class IIActive
e-1 Purple 37% phosphoric acid gel etchant 8010001
FDA UDI
Class IIActive
e-1 Orange 37% Phosphoric acid etchant gel 1602602
FDA UDI
Class IIActive
e-1 Seafoam 37% Phosphoric acid etchant gel 9010001
FDA UDI
Class IIActive

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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.

DateRecall No.ClassStatusReason
Feb 12, 2007Z-0800-2007—terminated

Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected.