Glass Ceramic

510(k) Number

K252789 ↗

FDA product code

EIH

Device class

Class II

Regulation

21 CFR Part 872.6660

Advisory committee

Dental

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code EIH (Powder, Porcelain).

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• Amber® Mill Amber MIll Z9518/W2 by Hass Corporation
• Ceramco® 3 Paste Opaque Shade Series C3-316 303025 by Dentsply International
• Zirlux 9012362 by HENRY SCHEIN, INC.
• K2 Li-Enamel Intensiv, EIO-NT (OPAL NEUTRAL), 20g. 3874003 by Yeti Dentalprodukte GmbH
• Celtra® Ceram 615148 by Dentsply International
• PENTRON HIGH STRENGTH PORCELAIN by Pentron Corp.
• CERESTORE DENTIN PORCELAIN by Johnson & Johnson Professionals, Inc.
• K2-HF ENAMEL opal orange, EIO-OR, 50g. 3862402 by Yeti Dentalprodukte GmbH
• Zirlux 9012373 by HENRY SCHEIN, INC.

• Glass Ceramic CAD/CAM B1

  Class II

  CE/MDR FDA 510(k) K252789 Active Cleared 8 Dec 2025 +1authorizations

• Glass Ceramic CAD/CAM D3

  Class II

  CE/MDR FDA 510(k) K252789 Active Cleared 8 Dec 2025 +1authorizations

• Glass Ceramic CAD/CAM D2

  Class II

  CE/MDR FDA 510(k) K252789 Active Cleared 8 Dec 2025 +1authorizations

• Glass Ceramic CAD/CAM BL4

  Class II

  CE/MDR FDA 510(k) K252789 Active Cleared 8 Dec 2025 +1authorizations

See all devices from Shenzhen Xiangtong Co., Ltd. →