# K063422: Bioaggregate

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Bioceramix, Inc.
- Decided: Nov 21, 2006 after 8 days
- Product code: KIF (Resin, Root Canal Filling)
- Device class: 2
- Regulation: 21 CFR 872.3820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K941780 (1995). 12 ancestors in all.
38 later devices descend from it; 4 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011009: White Mta Material, Dentsply International (2001) Summary page 1.
- K010348: Tantalum Beads - Radiographic Marker, Biomet, Inc. (2001) Summary page 1.
- K041350: Synthes (Usa) Chronos, Synthes (Usa) (2004) Summary page 1.
- K040278: Perioglas-Bioglass Bone Graft Substitute, Novabone Products, LLC (2004) Summary page 1.

## Most influential descendants
- K080917: Iroot SP (2008), 37 descendants of its own
- K082943: Iroot BP, Model Irbp 4609 (2009), 12 descendants of its own
- K170175: Endoseal Mta (2018), 8 descendants of its own
- K092715: Iroot BP Plus (2009), 7 descendants of its own
- K212983: Injectable Root Canal Bioceramic Sealer (2021), 4 descendants of its own

## Indications for use
Repair of Root Perforation Repair of Root Resorption Root End Filling Apexification Pulp Capping

Source page: https://510kreport.com/device/K063422
Methodology: https://510kreport.com/methodology