# K070854: GC MI Paste Plus

- Pathway: 510(k) (Special)
- Applicant: GC America, Inc.
- Decided: Apr 12, 2007 after 15 days
- Product code: EJR (Agent, Polishing, Abrasive, Oral Cavity)
- Device class: 1
- Regulation: 21 CFR 872.6030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
To be used for cleaning and polishing procedures as part of professionally administered prophylaxis treatment. To relieve dental hypersensitivity and for the management of tooth sensitivity following in-office bleaching procedures, ultrasonic, hand scaling or root planning.

Source page: https://510kreport.com/device/K070854
Methodology: https://510kreport.com/methodology