DCMhotbond Zircon
by Dental Creativ Management GmbH 510(k)
Active
510(k) K253191
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK253191 | Date21 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EIH
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.6660
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The DCMhotbond Zircon is a glassy ceramic solder designed for bonding zirconia (ZrO₂) frameworks and bridge segments. It facilitates a stable connection between pure ZrO₂ components during a single firing process, ensuring structural integrity in dental restorations. This material is specifically engineered for use in high-strength ceramic restorations, where precise bonding is critical. Its formulation supports the creation of aesthetically seamless and mechanically robust dental prosthetics.
DCMhotbond Zircon is supplied as a liquid solder paired with a complementary ceramic material, intended for professional dental laboratory use. The system requires mixing and application in a controlled firing cycle, adhering to standard dental laboratory protocols. It is classified under product code EIH and has received FDA 510(k) clearance under the Traditional pathway, with a decision date of May 21, 2026. The device is not intended for direct patient use but rather as an intermediary material in the fabrication of dental restorations.
From the manufacturer
Über DCMhotbond zircon Häufig müssen artreine Werkstoffe, also ZrO 2 Passiv-Fit-Elemente / Brückensegmente miteinander verbunden werden. DCMhotbond zircon ermöglicht den stabilen Verbund von ZrO 2 -Gerüsten in nur einem Brennvorgang.
Willkommen auf den Seiten der DCM Dental Creativ Management GmbH.
Manufacturer's product page: zirconnect
Other devices from Dental Creativ Management GmbH
Questions
AI-generated answers, 20 Sep 2026
What types of dental restorations is the DCMhotbond Zircon specifically designed to bond, and how does it differ from other soldering materials?
The DCMhotbond Zircon is engineered to bond zirconia (ZrO₂) frameworks and bridge segments, ensuring a stable connection during a single firing process. Unlike other soldering materials, it is formulated specifically for high-strength ceramic restorations, providing both aesthetic seamless integration and mechanical robustness. Its unique glassy ceramic composition allows for precise bonding critical in dental prosthetics, particularly where durability and precision matter most.
How is the DCMhotbond Zircon supplied, and what steps are required for its use in a dental laboratory?
The DCMhotbond Zircon is supplied as a liquid solder paired with a complementary ceramic material, intended exclusively for professional dental laboratory use. To use it, the liquid solder and ceramic material must be mixed according to standard dental laboratory protocols, then applied during a controlled firing cycle. This process ensures proper bonding of zirconia components while adhering to established fabrication techniques for dental restorations.
Is the DCMhotbond Zircon intended for direct patient application, or is it used as part of a larger fabrication process?
The DCMhotbond Zircon is explicitly not intended for direct patient use. Instead, it serves as an intermediary material in the fabrication of dental restorations, facilitating the bonding of zirconia frameworks and bridge segments during the manufacturing process. Its role is critical in creating the final prosthetic, which is then fitted to the patient.
What regulatory pathway was followed for FDA clearance of the DCMhotbond Zircon, and what does this mean for its use in clinical settings?
The DCMhotbond Zircon received FDA clearance under the Traditional 510(k) pathway, classified as substantially equivalent (SESE) to a predicate device. This means it has undergone review by the FDA’s Dental Advisory Committee to ensure safety and effectiveness for its intended use in bonding zirconia components in dental laboratories. Clinicians and laboratories can rely on this clearance as evidence of regulatory scrutiny before incorporating it into their workflow.
What product code does the DCMhotbond Zircon fall under, and what does this indicate about its classification?
The DCMhotbond Zircon is classified under product code EIH, which categorizes it as a dental soldering material. This classification aligns with its role in bonding ceramic components during the fabrication of dental prosthetics, distinguishing it from other dental devices like implants or restorative materials. The EIH code reflects its specialized function in laboratory-based dental restoration processes.