# K960464: C & B Metabond (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Feb 26, 1996 after 27 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
No predicates in its family tree.
15 later devices descend from it; 7 cite it directly.
0 of 16 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
- K012316: Permacem / Permacem Dual (2001), 5 descendants of its own
- K991711: Bistite II SC (1999), 5 descendants of its own
- K011685: Bistite II DC (2001), 3 descendants of its own
- K150727: Estecem (2015), 2 descendants of its own
- K171226: Tokuyama Universal Bond (2017), 1 descendant of its own

Source page: https://510kreport.com/device/K960464
Methodology: https://510kreport.com/methodology