# K152652: PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement

- Pathway: 510(k) (Traditional)
- Applicant: Gaia Dental Products, Inc.
- Decided: Apr 5, 2016 after 202 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925032 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051427: GC Fuji Fil LC, GC America, Inc. (2005) Summary page 4.
- K052235: LCR, 3M Company (2005) Summary page 4.

## Indications for use
PackFil RMGI Restorative Cement is indicated for filling and restoration of tooth of following typical applications: • Primary teeth restorations; • Class I restorations; • Class III and V restorations; • Transitional restorations; • Base liners or laminated/sandwich restorations; • Selective core build-ups (>50% coronal tooth intact);

Source page: https://510kreport.com/device/K152652
Methodology: https://510kreport.com/methodology