Gc Mi Paste Plus

510(k) Number

K070854 ↗

FDA product code

EJR

FDA applicant

GC America, Inc.

Device class

Class I

Regulation

21 CFR Part 872.6030

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 EJR (Agent, Polishing, Abrasive, Oral Cavity).

• NIMETIC POLISHING PASTE by Espe GmbH (Us)
• TEMREX SATIN POLISHING PASTE 5200, 5210 by Temrex Corp.
• PROPHY CARE PASTE by Imd, Inc.
• VISION PROPHY PASTE WITH FLUORIDE by Block Drug Company, Inc.
• Diamond ACI & ACII 4000002090 by Dentscare Ltda
• CleanJoy 6099 by VOCO GmbH
• PROPHY CARE SOLUTION by Imd, Inc.
• SCI-PRO, PROPHYLAXIS PASTE by SCIENTIFIC PHARMACEUTICALS, INC.
• PULPDENT DIAMOND POLISH by Pulpdent Corporation
• CUPRIDENT by Biosystems

• G-Bond Universal 10042011

  Class II

  FDA 510(k) K251124 Active Cleared 2 Oct 2025 GUDID on market

• G-Bond Universal 10042010

  Class II

  FDA 510(k) K251124 Active Cleared 2 Oct 2025 GUDID on market

• G-Bond Universal 10042014

  Class II

  FDA 510(k) K251124 Active Cleared 2 Oct 2025 GUDID on market

• G-Bond Universal 10042012

  Class II

  FDA 510(k) K251124 Active Cleared 2 Oct 2025 GUDID on market

See all devices from Gc America Inc. →