Manufacturer registered with FDA
Innovative Bioceramix, Inc.
Burnaby, Canada. Lists 2 dental device types with FDA across 1 registered establishment, and holds 8 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 23
- 510(k) clearances
- 82006–2023
- Markets registered in
- 932 registrations outside the US
- Establishments
- 1Canada
510(k) clearances per year, 2000–2026
Registered in 9 markets
Where regulators' registries name Innovative Bioceramix, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Innovative Bioceramix, Inc. | 8 clearances | 2006–2023 | Below |
| Canada | Health Canada | Registration holder | INNOVATIVE BIOCERAMIX INC. | 11 | 2006–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Innovative BioCeramix, Inc.Innovative BioCeramix Inc. | 11 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Innovative BioCeramix Inc | 3 | 2018–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Innovative BioCeramix Inc. | 2 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Innovative BioCeramix Inc. | 2 | — | Pure Global AI |
| China | NMPA | Registration holder | 创新生物陶瓷有限公司Innovative Bioceramix,Inc. | 1 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Innovative BioCeramix Inc. | 1 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Innovative BioCeramix Inc. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Innovative Bioceramix, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | EdgeBioceramic RetroFill and Perforation Repair Material .5gEdgeBioceramic Sealer 2gEdgeBioceramic ThermalFlow 1.5gEndoSequence BC Pediatric Putty .5g 1PEndoSequence BC Pediatric Putty .5g 6PEndoSequence BC RRM 1.5G 2PEndoSequence BC RRM 1G 1PEndoSequence BC RRM Fast Set Putty 1PEndoSequence BC RRM Putty .5GEndoSequence BC RRM Putty 3G 1P 12 moreEndoSequence BC Sealer 1.6G 2PEndoSequence BC Sealer 2G 1PEndoSequence BC Sealer HiFlow 1.5G 1PEndoSequence BC Sealer HiFlow 1.5G 2PEndoSequence BC Sealer Trial PackiRoot FMTotalFill BC RRM 1G 1PTotalFill BC RRM Fast Set Putty 1PTotalFill BC RRM Putty 2.5G 1PTotalFill BC Sealer 1.5G 1PTotalFill BC Sealer 2G 1PTotalFill BC Sealer HiFlow 1.5G 1P | 2008 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | BC Tips 15P | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Innovative Bioceramix, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 31 May 2023 | K231259 | iRoot SP Plus | KIF Root Canal Filling Resin |
| 22 Nov 2022 | K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material | KIF Root Canal Filling Resin |
| 18 Sep 2014 | K130312 | IROOT FM | KIF Root Canal Filling Resin |
| 3 Dec 2010 | K102867 | IROOT FS | KIF Root Canal Filling Resin |
| 28 Sep 2009 | K092715 | IROOT BP PLUS | KIF Root Canal Filling Resin |
| 6 Jan 2009 | K082943 | IROOT BP, MODEL IRBP 4609 | KIF Root Canal Filling Resin |
| 9 Apr 2008 | K080917 | IROOT SP | KIF Root Canal Filling Resin |
| 21 Nov 2006 | K063422 | BIOAGGREGATE | KIF Root Canal Filling Resin |
Some of these clearances are listed with FDA today by another company: HSG-S Corp (2), Peter Brasseler Holdings, LLC (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Innovative BioCeramix, IncFDA reg. 3006313979 | Burnaby British Columbia, Canada | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9089383). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.