Estemp Implant, Estemp Clear
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K134021 FDA 510(k)
- FDA Product Code
- EMA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3275 FDA 510(k)
- Regulation Number
- 872.3275 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Estemp Implant and Estemp Clear are dental cements classified under FDA regulation 872.3275. These devices are designed to bond dental restorations, such as crowns, bridges, and inlays, to tooth structures, ensuring stability and longevity in dental prosthetics. They are formulated to provide a durable seal while maintaining biocompatibility with oral tissues.
These dental cements are supplied as reusable materials for dental professionals and are intended for use in clinical settings. They are not sterile at the point of sale but are typically sterilized or prepared under aseptic conditions prior to application. The devices are regulated under the FDA’s 510(k) pathway, with a determination of substantial equivalence to predicate products, and comply with both the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) in the EU. Multiple registration numbers and FEI numbers indicate their distribution across various dental applications and markets.
Frequently asked questions
Are the Estemp Implant and Estemp Clear dental cements intended for single-use or can they be reused in a clinical setting?
The Estemp Implant and Estemp Clear are explicitly described as reusable materials for dental professionals, meaning they are designed to be used multiple times in clinical settings. Since they are not sterile at the point of sale, they must be sterilized or prepared under aseptic conditions prior to each use, ensuring proper infection control.
How are the Estemp Implant and Estemp Clear dental cements regulated in the U.S. and Europe?
In the U.S., these dental cements are regulated under FDA’s 510(k) pathway, with a determination of substantial equivalence to predicate products. They fall under FDA regulation 872.3275 and were cleared through a traditional 510(k) review by the Dental Advisory Committee. In Europe, they comply with both the Medical Device Directive (MDD) and the Medical Device Regulation (MDR), as indicated by their regulatory authorizations.
What types of dental restorations can the Estemp Implant and Estemp Clear be used to bond?
The Estemp Implant and Estemp Clear are designed to bond dental restorations such as crowns, bridges, and inlays to tooth structures. Their purpose is to provide a durable seal while maintaining biocompatibility with oral tissues, ensuring stability and longevity for these prosthetic applications.
Are the Estemp Implant and Estemp Clear dental cements sterile when purchased?
No, the Estemp Implant and Estemp Clear are not sterile at the point of sale. They are intended to be sterilized or prepared under aseptic conditions prior to clinical use, as they are reusable materials meant for professional dental settings.
What should I consider when storing the Estemp Implant and Estemp Clear dental cements?
While the data does not specify storage conditions explicitly, as reusable materials, these dental cements should be stored in a clean, dry environment to maintain their integrity until sterilization or preparation for use. Proper storage ensures they remain effective and uncontaminated for repeated clinical applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K134021 | Class II | Active |
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Manufacturer
- Manufacturer
- Spident Co., Ltd.
Sources (2)
- FDA 510(k) K134021 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026