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.
Summary
Eternal Art Porcelain Powders is a dental prosthetic material — product code EIH covers dental porcelain feldspathic ceramics used to fabricate crowns, veneers, and fixed prosthetic restorations. It's a mature materials category with well-characterized predicate products.
Dental panel, Traditional 510(k). EIH clearances are routine and turn on composition, processing parameters, and biocompatibility testing against the predicate. The category sees regular filings from both US and international dental-materials manufacturers.
Shandong Huge Dental Material Corporation files from Rizhao City, China. Three-month review clock. Chinese dental-materials companies have become a substantial share of EIH filings over the last decade.
Clearance details
- Applicant
- Shandong Huge Dental Material Corporation
- Product code
- Code EIH
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rizhao City, CN
Data sourced from openFDA. This site is unofficial and independent of the FDA.