Cimara
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by VOCO GmbH
Identity
- Trade Name
- Cimara EUDAMED
- Device Name
- Cimara EUDAMED
- Model / Reference
- syringe EUDAMED1575 EUDAMEDAmpoule EUDAMED1197 EUDAMEDbottle EUDAMED1196 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E22115751 EUDAMEDE22111971 EUDAMEDE22111961 EUDAMED
- Basic UDI-DI
- B-E22115751 EUDAMEDB-E22111971 EUDAMEDB-E22111961 EUDAMED
- 510(k) Number
- K110589 FDA 510(k)
- FDA Product Code
- EBF FDA 510(k)
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Cimara is a dental adhesive resin used for bonding restorative materials to tooth structure. Classified under product code EBF (Dental Adhesives, Resin-Based), it facilitates durable bonding in restorative dentistry by creating a strong interface between dental materials and enamel or dentin.
Supplied as a two-component system, Cimara is intended for single-use and requires proper mixing before application. The device is regulated under the FDA’s 510(k) pathway with a clearance date of May 27, 2011, and complies with the Medical Device Directive (MDD). Storage conditions and sterility are not specified in the data, but adherence to manufacturer instructions is required for clinical use.
Frequently asked questions
What is Cimara used for in dental procedures, and how does it differ from other bonding agents?
Cimara is a resin-based dental adhesive designed specifically to bond restorative materials—such as fillings or crowns—to tooth enamel or dentin. Unlike some alternatives, it creates a strong, durable interface between the dental material and tooth structure, ensuring long-lasting adhesion in restorative dentistry. Its two-component system requires mixing before use, which helps achieve optimal bonding performance.
Is Cimara intended for single-use or repeated applications, and how should it be handled?
Cimara is supplied as a single-use device, meaning each application requires a fresh set of components. Since it is a two-component system, proper mixing is essential before application to ensure effective bonding. The manufacturer’s instructions must be followed closely to avoid compromising performance or sterility.
What regulatory pathways has Cimara undergone, and how does this affect its use in clinical settings?
Cimara has been cleared through the FDA’s 510(k) pathway as substantially equivalent to a predicate device, with clearance granted on May 27, 2011. It also complies with the Medical Device Directive (MDD). This regulatory status confirms its safety and effectiveness for bonding restorative materials in dentistry, but clinicians should always refer to the manufacturer’s guidelines for proper use and compliance.
How is Cimara supplied, and what should clinicians consider when storing it?
Cimara is supplied as a two-component dental adhesive system, requiring mixing before application. While specific storage conditions and sterility details aren’t provided in the data, adherence to the manufacturer’s instructions is critical to maintain product integrity. Clinicians should store it in a clean, dry environment away from extreme temperatures until use.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K110589 | Class II | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (4)
- FDA 510(k) K110589 24 fields · synced Oct 6, 2026
- EUDAMED 6e655cba-4bec-4c16-a1cd-78aca0d68d8c 61 fields · synced Jul 12, 2026
- EUDAMED 7b3a0145-1be9-4650-b592-058538993b38 61 fields · synced Jul 17, 2026
- EUDAMED c2223b45-6ed5-4d66-b5c9-45f5a4ca75de 61 fields · synced Aug 4, 2026