# K951220: Hema-Glu

- Pathway: 510(k) (Traditional)
- Applicant: Health-Dent Intl., Inc.
- Decided: May 12, 1995 after 53 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K161077: RnD TE and RnD SE (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K951220
Methodology: https://510kreport.com/methodology