Shandong Huge Dental Material Corporation · Class II · Cleared Apr 9, 2026
| K-number | K260067 |
| Device name | Eternal Art Porcelain Powders |
| Applicant | Shandong Huge Dental Material Corporation |
| Product code | EIH |
| Device class | Class II |
| Decision date | Apr 9, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 872.6660 |
Eternal Art Porcelain Powders is a dental veneering material used for color staining and glazing of ceramic restorations such as zirconia or glass-ceramic substrates in crowns and bridges. The device is supplied in three forms: dry powder, blending liquid (for mixing), and pre-mixed stain/glaze paste, classified as a Type I ceramic product.
The subject device and predicate device (Upcera Glaze) share the same main composition: glass powder for the powder form and purified water with organic solvents for the blending liquid. Both are provided in powder, liquid, and paste physical forms and are non-sterile prescription-use devices. Minor compositional differences exist but do not raise new safety risks.
ISO 6872:2024 (Dentistry—Ceramic materials), ISO 7405 (Biocompatibility of dental materials), and ISO 10993 (Biocompatibility of medical devices). Testing covered uniformity, freedom from extraneous materials, radioactivity, mixing and condensation properties, flexural strength, chemical solubility, thermal expansion, and glass transition temperature.
The device demonstrates substantial equivalence because it has identical indications for use, the same main components and physical forms as the predicate, substantially equivalent physical properties per ISO 6872:2024, and minor compositional differences with no new safety concerns. Biocompatibility testing per ISO 7405 and ISO 10993 confirmed safety equivalent to the predicate device.
View the full FDA submission: accessdata.fda.gov