Data / Medical devices / Canada / Innovative BioCeramix, Inc
Innovative BioCeramix, Inc: FDA-registered device maker in Burnaby British Columbia, Canada, 5 510(k) clearances
Innovative BioCeramix, Inc is registered with the FDA (registration 3006313979) in Burnaby British Columbia, Canada. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 18, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006313979
- Address
- 101 - 8218 North Fraser Way, Burnaby British Columbia, Canada, V3N 0E9
- Owner or operator
- INNOVATIVE BIOCERAMIX INC. (9089383)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- April 14, 2008
- Registered through
- 2027
- Brand names listed
- BC Tips 15P, EdgeBioceramic RetroFill and Perforation Repair Material .5g, EdgeBioceramic Sealer 2g, EdgeBioceramic ThermalFlow 1.5g, EndoSequence BC Pediatric Putty .5g 1P, EndoSequence BC Pediatric Putty .5g 6P, EndoSequence BC RRM 1.5G 2P, EndoSequence BC RRM 1G 1P and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Resin, Root Canal Filling | KIF | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 18, 2014 | K130312 | IROOT FM | KIF | Substantially Equivalent | Innovative Bioceramix, Inc. | accessdata.fda.gov |
| December 3, 2010 | K102867 | IROOT FS | KIF | Substantially Equivalent | Innovative Bioceramix, Inc. | accessdata.fda.gov |
| September 28, 2009 | K092715 | IROOT BP PLUS | KIF | Substantially Equivalent | Innovative Bioceramix, Inc. | accessdata.fda.gov |
| January 6, 2009 | K082943 | IROOT BP, MODEL IRBP 4609 | KIF | Substantially Equivalent | Innovative Bioceramix, Inc. | accessdata.fda.gov |
| April 9, 2008 | K080917 | IROOT SP | KIF | Substantially Equivalent | Innovative Bioceramix, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 18, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.