# K193388: GlassLok Kits, GlassLok Powder, GlassLok Liquid

- Pathway: 510(k) (Traditional)
- Applicant: Reliance Orthodontic Products, Inc.
- Decided: Apr 27, 2020 after 143 days
- Product code: DYH (Adhesive, Bracket And Tooth Conditioner, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981461 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981461: GC Fuji Ortho LC, GC America, Inc. (1998) Summary page 4.

## Indications for use
GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office.

Source page: https://510kreport.com/device/K193388
Methodology: https://510kreport.com/methodology