Easy Glaze
by VOCO GmbH
510(k) K082285
Active
Valid until
No date given
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK082285 | Date24 Oct 2008 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- EBD
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3310
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
Easy Glaze is a dental resin-based coating material designed for use in restorative dentistry. Classified as a filling material and resin coating, it is intended to provide a protective layer over dental restorations, enhancing aesthetics and durability while maintaining biocompatibility with oral tissues.
This product is supplied as a single-use system and is regulated under the FDA’s 510(k) pathway with a Traditional clearance, classified as a Class II device (FDA code 872.3310). It is intended for use in dental offices and clinics, with no specific sterility requirements noted beyond standard dental practice protocols. The material is non-magnetic and MRI-safe, ensuring compatibility with magnetic resonance imaging environments. Storage should follow manufacturer guidelines to preserve integrity, and it is authorized under the Medical Device Directive (MDD) in Europe.
Other devices from VOCO GmbH
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of Easy Glaze in dental restorations, and how does it benefit the patient?
Easy Glaze is a resin-based coating designed to create a protective layer over dental restorations, improving both aesthetics and durability. By applying this material, clinicians can enhance the appearance of the restoration while reducing wear and tear, ensuring a longer-lasting and more visually pleasing result for the patient.
Is Easy Glaze intended for single-use only, and if so, how does this affect clinical workflow?
Yes, Easy Glaze is supplied as a single-use system, meaning each application requires a new unit. This design ensures sterility and reduces cross-contamination risks, aligning with standard dental practice protocols. Clinicians should account for this in their workflow to maintain efficiency while adhering to hygiene standards.
How should Easy Glaze be stored to maintain its integrity, and are there any special considerations for handling?
Easy Glaze should be stored according to the manufacturer’s guidelines provided by VOCO GmbH to preserve its properties. While no specific sterility requirements beyond standard dental practice are mentioned, proper storage conditions—such as protecting it from moisture, extreme temperatures, or direct light—are critical to ensure the material remains effective for its intended use.
Can Easy Glaze be used in patients who require MRI scans, and why is this important?
Yes, Easy Glaze is non-magnetic and MRI-safe, meaning it can be used in patients who need magnetic resonance imaging without interference. This is particularly important for clinicians treating patients who may require future MRI scans, as it eliminates concerns about potential artifacts or safety risks during imaging.
What regulatory pathways does Easy Glaze follow, and how does this affect its availability in different markets?
Easy Glaze is cleared under the FDA’s 510(k) pathway as a Class II device, indicating it has been deemed substantially equivalent to a predicate device. It is also authorized under the Medical Device Directive (MDD) in Europe, ensuring compliance with regional regulations. This dual authorization allows for broader availability in both the U.S. and European markets, though clinicians should verify local compliance requirements.