# K013446: Glusite, Model GLU002

- Pathway: 510(k) (Traditional)
- Applicant: Glustitch, Inc.
- Decided: Dec 20, 2001 after 64 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: 1 generation back to K980159 (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)
- K980159: Octyldent (2-Octyl Cyanoacrylate), 02A01, Closure Medical Corp. (1998) Summary page 1.

## Indications for use
GluSite is indicated for use as dental cement for bonding dental materials such as crowns, caps, and pins, or temporarily attaching a fiber to the surface of the tooth in a procedure to treat periodontal disease.

Source page: https://510kreport.com/device/K013446
Methodology: https://510kreport.com/methodology