NATURAZ SERIES - B60
by Dental Solutions, Inc. 510(k)
Active
510(k) K091096
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK091096 | Date18 Jun 2009 | 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- Withdrawn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, 1 Oct 2026
The NaturaZ Series, Models B16, B20, B42, B60, B98, and B100 are pre-formed porcelain powders classified under Porcelain Powder for Clinical Use (21 CFR 872.6660). These materials serve as raw components for dental laboratory professionals to fabricate custom dental prosthetics, including crowns, bridges, or inlays, restoring both function and aesthetics to patients.
Supplied as pre-formed powders, these models are intended for single-use in dental laboratory settings. The device is regulated under FDA 510(k) clearance (K091096) and falls under the Dental (DE) advisory committee, with no third-party involvement. Each model number corresponds to a specific powder formulation, ensuring compatibility with prosthetic fabrication processes. Storage and handling follow standard dental laboratory protocols for porcelain materials.
Other devices from Dental Solutions, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are the NaturaZ Series porcelain powders used for in dental labs?
The NaturaZ Series porcelain powders (Models B16, B20, B42, B60, B98, B100) are raw materials designed for dental laboratory professionals to create custom dental prosthetics. These include crowns, bridges, and inlays, restoring both the function and aesthetics of a patient’s teeth. Each model corresponds to a specific powder formulation, ensuring compatibility with different prosthetic fabrication processes.
Are the NaturaZ porcelain powders intended for single-use or reuse?
The NaturaZ porcelain powders are explicitly supplied for single-use in dental laboratory settings. This design ensures consistency in prosthetic fabrication and minimizes cross-contamination risks, adhering to standard dental laboratory protocols for porcelain materials.
How should NaturaZ porcelain powders be stored?
Storage and handling of NaturaZ porcelain powders follow standard dental laboratory protocols for porcelain materials. This typically includes keeping the powders in a clean, dry environment, away from direct sunlight or extreme temperatures, and in their original packaging to prevent contamination or degradation.
What distinguishes each model number in the NaturaZ Series?
Each model number (B16, B20, B42, B60, B98, B100) in the NaturaZ Series represents a unique powder formulation tailored for specific prosthetic fabrication needs. These differences ensure compatibility with various dental techniques and materials used in creating crowns, bridges, or inlays, allowing for precise customization in dental restorations.
What regulatory pathway does the NaturaZ Series porcelain powder follow?
The NaturaZ Series porcelain powders are regulated under the FDA’s 510(k) clearance pathway, specifically with clearance number K091096. They are classified under Porcelain Powder for Clinical Use (21 CFR 872.6660) and fall under the Dental (DE) advisory committee. The device is determined to be substantially equivalent to a predicate, with no third-party involvement in the review process.