Porcelain Powder (Enamel/ Modifier, Stain/Glaze, Stain/Glaze-A, Modeling Fluid )

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Porcelain Powder

Model / Reference

4g-Stain/Glaze

Primary DI / UDI-DI

06976087531529, 06976087531482, 06976087531222, 06976087531581, 06976087531093, 06976087531154, 06976087531659, 06976087539730, 06976087531673, 06976087531376, 06976087531642, 06976087531536, 06976087531390, 06976087531161, 06976087531284

Basic UDI-DI

B-06976087531529, B-06976087531482, B-06976087531222, B-06976087531581, B-06976087531093, B-06976087531154, B-06976087531659, B-06976087539730, B-06976087531673, B-06976087531376, B-06976087531642, B-06976087531536, B-06976087531390, B-06976087531161, B-06976087531284

510(k) Number

K250025 ↗

FDA Product Code

EIH

EMDN Code

Q01010199 Dental restoration devices - other

Device Class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 872.6660

EU market of registration

Germany

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  Class IIa

  CE/MDR

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  Class IIa

  CE/MDD

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  Class IIa

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  Class IIa

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  CE/MDR CN26/00001383 Active Valid to Mar 2031

See all devices from Aidite (Qinhuangdao) Technology Co., Ltd. →

• What types of dental restorations can this porcelain powder be used for, and how does it contribute to the process?

  This porcelain powder is designed for use in dental laboratories to fabricate crowns, bridges, and veneers. It serves multiple purposes: as an enamel modifier to strengthen the ceramic structure, as a stain for achieving precise color matching, as a glaze for surface finishing, and as a modeling fluid to aid in shaping the restoration. The powder is mixed with water or another liquid to create a workable slurry, allowing for detailed application during the fabrication of these restorations.

• Is this porcelain powder sterile, and how should it be stored before use?

  The porcelain powder is supplied in a non-sterile dry form, meaning it requires mixing with water or another liquid to prepare it for use. Since it is not sterile, it must be handled in a clean environment, such as a dental laboratory, following standard aseptic practices. Storage instructions are not explicitly detailed, but generally, dry powders like this should be kept in a cool, dry place, protected from moisture and contamination, until ready for use.

• Can this porcelain powder be reused after mixing, or is it intended for single-use only?

  The porcelain powder is intended for single-use after mixing with water or another liquid to form a slurry. Once mixed, the slurry becomes a workable material for application in dental restorations, but it is not designed for reuse. Any unused mixed slurry should be discarded to maintain proper handling and prevent contamination.

• What regulatory pathways has this porcelain powder followed, and what does that mean for its use in dental practices?

  This porcelain powder has undergone FDA 510(k) clearance (K250025) under the Traditional pathway, with a decision of Substantially Equivalent (SESE) to predicate devices. It is classified as a Class II dental device under 21 CFR 872.6660, meaning it has been reviewed by the FDA’s Dental (DE) Advisory Committee and is considered safe and effective for its intended use in dental laboratories. Clinicians and laboratories can rely on this clearance as evidence of its regulatory compliance for use in fabricating dental restorations.