CEREC Opti Spray
510(k) K080882
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK080882 | Date11 Apr 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ELW
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3660
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The CEREC Opti Spray is a Material, Impression device used in dental chairside CAD/CAM workflows. It functions as an intraoral coating material designed to enhance optical scanning accuracy for digital impressions of dental restorations, ensuring precise surface capture for computer-aided design and manufacturing (CAD/CAM) applications.
This spray is applied directly within the oral cavity to facilitate homogeneous coating of the restoration surface, improving the optical impression process for the CEREC system. Supplied as a single-use, non-sterile material, it is intended for chairside use in dental offices. The device holds an FDA 510(k) clearance under the classification of Device Class II and is regulated under the Medical Device Regulation (MDR) 872.3660 for dental materials.
Other devices from SIRONA Dental Systems GmbH
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the CEREC Opti Spray in a dental CAD/CAM workflow?
The CEREC Opti Spray is designed as an intraoral coating material to improve the accuracy of optical scanning for digital impressions of dental restorations. By applying a homogeneous coating directly inside the mouth, it enhances surface capture during the scanning process, ensuring precise data for computer-aided design and manufacturing (CAD/CAM) applications in dental restorations.
Is the CEREC Opti Spray intended for single-use or reusable applications, and why?
The CEREC Opti Spray is explicitly supplied as a single-use material. This is because it is non-sterile and intended for chairside use in dental offices, where maintaining hygiene and preventing cross-contamination is critical. Single-use ensures each application is fresh and uncontaminated, aligning with dental best practices for patient safety.
How is the CEREC Opti Spray regulated, and what does its classification mean for dental professionals?
The CEREC Opti Spray holds FDA 510(k) clearance under Device Class II, meaning it has been deemed substantially equivalent to a legally marketed predicate device. This classification indicates it undergoes stricter regulatory oversight than Class I devices but does not require the same rigorous scrutiny as Class III. Clinically, this means it has been evaluated for safety and effectiveness in its intended use—enhancing optical scanning accuracy for CAD/CAM dental restorations—while still allowing for streamlined access for dental professionals.
What storage or handling considerations should be kept in mind for the CEREC Opti Spray?
Since the CEREC Opti Spray is non-sterile and intended for single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity. As it is not sterile, it must be handled in a manner that prevents contamination before use. Always follow manufacturer guidelines for proper storage to ensure optimal performance and compliance with dental office protocols.
Does the CEREC Opti Spray come in different sizes or models, and if so, how might that affect its use?
The provided data does not specify varying sizes or models for the CEREC Opti Spray, implying it is likely supplied in a standardized formulation for universal application within the CEREC system. This consistency ensures compatibility across different dental restorations and scanning scenarios, eliminating the need for clinicians to select a specific variant based on the procedure. Always verify compatibility with your CEREC system’s software and hardware before use.