Eternal Art Porcelain Powders— 510(k) K260067
Substantially EquivalentShandong Huge Dental Material Corporation
FDA 510(k) clearance K260067 for Eternal Art Porcelain Powders, Substantially Equivalent on 2026-04-09. Applicant: Shandong Huge Dental Material Corporation. Device class: 2.
Summary
Eternal Art Porcelain Powders are dental porcelain powders under EIH. Dental labs layer and fire these to build crowns, veneers, and other ceramic restorations.
Class II, 21 CFR 872.6660. The Dental panel reviewed it as a Traditional 510(k).
Shandong Huge Dental Material filed from Rizhao, China. Review took exactly 90 days (January 9 to April 9, 2026). Porcelain powders are a mature category where clearance mostly comes down to composition and biocompatibility testing.
Clearance details
- Applicant
- Shandong Huge Dental Material Corporation
- Product code
- Code EIH
- Device class
- Class 2
- Regulation
- 21 CFR 872.6660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rizhao City, CN
Recent devices under product code EIH
view allMore clearances from Shandong Huge Dental Material Corporation
view allData sourced from openFDA. This site is unofficial and independent of the FDA.