K260067

Substantially Equivalent

Eternal Art Porcelain Powders

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.

Applicant: Shandong Huge Dental Material Corporation
Product code: EIH
Advisory panel: Dental
Date received: 2026-01-09
Decision date: 2026-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rizhao City, CN

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Data sourced from openFDA. This site is unofficial and independent of the FDA.