# K991172: Ionosit Bond

- Pathway: 510(k) (Traditional)
- Applicant: Dmg Chemisch Pharmazeutische Fabrik GmbH
- Decided: May 17, 1999 after 40 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 K882821 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962065: 3M Vitrebond Light Cure Glass Ionomer/Base, 3M Company (1996) Summary page 1.
- K882821: Vitrabond Light Cure Glass Ionomer Liner, 3M Company (1988) Summary page 1.

## Indications for use
Ionosit Bond is indicated for use in lining and basing applications under composite, amalgam, ceramic and metal restorations.

Source page: https://510kreport.com/device/K991172
Methodology: https://510kreport.com/methodology