Rainbow Paste Stain

510(k) Number

K151731 ↗

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).

• Amber® Mill Amber MIll P9812/D2 by Hass Corporation
• Amber® Mill Meso Amber Mill Meso C16/A3(L) by Hass Corporation
• Zirlux 9012336 by HENRY SCHEIN, INC.
• 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
• Glass Ceramic (EIH) by SHENZHEN XIANGTONG CO.,LTD.
• PENTRON HIGH STRENGTH PORCELAIN by Pentron Corp.
• CERESTORE DENTIN PORCELAIN by Johnson & Johnson Professionals, Inc.

• Initiator Angiographic Catheter

  Class III

  CE/MDD

• GENOSS PTA balloon catheter

  Class IIa

  CE/MDD

• Initiator Angiographic Catheter

  Class III

  CE/MDD

• GENOSS PTA balloon catheter

  Class IIa

  CE/MDD

See all devices from Genoss →