# Innovative Bioceramix, Inc.

- Location (FDA's records): Vancouver, Bc, CA
- FDA decisions: 8 (2006–2023): 8 510(k) clearances
- Product codes: KIF (8)
- Predicates its devices cite: 29 (14 its own); citations of its devices by later devices: 28 (14 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dentsply Intl.: 2 (https://510kreport.com/company/dentsply-intl)
- Bisco, Inc.: 2 (https://510kreport.com/company/bisco)
- Dentsply International, Inc.: 2 (https://510kreport.com/company/dentsply-international)
- Sigma Chemical Co.: 1 (https://510kreport.com/company/sigma-chemical)
- Williams Dental Co., Inc.: 1 (https://510kreport.com/company/williams-dental)
- Exactech, Inc.: 1 (https://510kreport.com/company/exactech)
- Biomatlante: 1 (https://510kreport.com/company/biomatlante)
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)

## Firms that cite its devices most
- Maruchi: 3 (https://510kreport.com/company/maruchi)
- Beijing C-Root Dental Medical Devices Co., Ltd.: 2 (https://510kreport.com/company/beijing-c-root-dental-medical-devices)
- Meta Biomed Co., Ltd.: 2 (https://510kreport.com/company/meta-biomed)
- Angelus Industria DE Produtos Odontologicos S/A: 2 (https://510kreport.com/company/angelus-industria-de-produtos-odontologicos-s-a)
- Enpuno Biotechnology Co., Ltd.: 1 (https://510kreport.com/company/enpuno-biotechnology)
- Kerr Corporation: 1 (https://510kreport.com/company/kerr)
- Sonendo, Inc.: 1 (https://510kreport.com/company/sonendo)
- Septodont, Inc.: 1 (https://510kreport.com/company/septodont)

## Its most-cited devices
- K080917: Iroot SP (2008), cited by 12
- K092715: Iroot BP Plus (2009), cited by 5
- K082943: Iroot BP, Model Irbp 4609 (2009), cited by 5
- K063422: Bioaggregate (2006), cited by 4
- K102867: Iroot FS (2010), cited by 2

## Recent decisions
- K231259: iRoot SP Plus (May 31, 2023)
- K222992: iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material (Nov 22, 2022)
- K130312: Iroot FM (Sep 18, 2014)
- K102867: Iroot FS (Dec 3, 2010)
- K092715: Iroot BP Plus (Sep 28, 2009)
- K082943: Iroot BP, Model Irbp 4609 (Jan 6, 2009)
- K080917: Iroot SP (Apr 9, 2008)
- K063422: Bioaggregate (Nov 21, 2006)

Source page: https://510kreport.com/company/innovative-bioceramix