Data / Medical devices / Canada / Diadent Group Intl., Inc.
Diadent Group Intl., Inc.: FDA-registered device maker in Vancouver British Columbia, Canada, 22 510(k) clearances
Diadent Group Intl., Inc. is registered with the FDA (registration 9615399) in Vancouver British Columbia, Canada. It lists 25 device types. The FDA files 22 510(k) clearances under its listings, the newest dated September 16, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615399
- FEI number
- 3002574147
- Address
- Ross Street, Vancouver British Columbia, Canada, V5X 0L1
- Owner or operator
- DIADENT GROUP INTL., INC. (9035015)
- Roles
- Exporter to the US, Foreign private label distributor, Repackager or relabeler
- First device listed
- September 10, 1998
- Registered through
- 2026
- Brand names listed
- ABSORBENT PAPER POINTS(Sterile Paper Points), Barbed Broaches, Brush Handle, Brush Tips, Cheek Retractors, D-Lux+, DIA-CEM, DIA-ENDORING and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Retractor, Dental | EIF | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Broach, Endodontic | EKW | 1 | Foreign private label distributor | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Condenser, Amalgam And Foil, Operative | EKG | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Gutta-Percha | EKM | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Instrument, Filling, Plastic, Dental | EIY | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Mixer, Cement, For Clinical Use | JDZ | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Plugger, Root Canal, Endodontic | EKR | 1 | Foreign private label distributor | accessdata.fda.gov |
| Point, Paper, Endodontic | EKN | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Preparer, Root Canal Endodontic | EKQ | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Exporter to the US, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Tip, Rubber, Oral Hygiene | JEW | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Zinc Oxide Eugenol | EMB | 1 | Exporter to the US, Foreign private label distributor | 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 16, 2026 | K254152 | Dia-X Sil Light Body | ELW | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| September 16, 2026 | K254142 | Dia-X Sil Heavy Body | ELW | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| July 9, 2026 | K261166 | DIA-CEM | EMA | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| June 2, 2026 | K261093 | DIAFIL | EBF | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| May 19, 2026 | K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | EBF | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| March 19, 2026 | K254112 | Dia-X Sil Bite | ELW | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| July 28, 2023 | K231552 | Dia-Cem | EMA | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| June 15, 2022 | K220804 | Dia-X Bond Universal | KLE | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| June 28, 2021 | K210421 | Diafil & Diafil Capsule | EBF | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| March 25, 2021 | K210333 | DiaPaste | KIF | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| September 18, 2020 | K200174 | DIA-ROOT BIO MTA | KIF | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| August 7, 2020 | K200809 | D-LUX+ | EBZ | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| June 25, 2020 | K200175 | DIA-ROOT BIO Sealer | KIF | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| May 26, 2020 | K192392 | DiaPlus | KLE | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| March 27, 2020 | K190091 | Diapaste | KIF | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| March 25, 2020 | K192284 | DiaFil Flow | EBF | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| March 20, 2020 | K192510 | DIAFIL & DIAFIL Capsule | EBF | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| February 13, 2020 | K192158 | DiaTemp | EBG | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| February 13, 2020 | K192022 | DiaTemp Flow | EBG | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| February 7, 2020 | K192273 | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit | KLE | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| September 26, 2019 | K182009 | Dia-Proseal | KIF | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
| June 3, 2019 | K182625 | Diapex Plus | KIF | Substantially Equivalent | DiaDent Group International | accessdata.fda.gov |
Compare with other makers
- All makers of Zinc Oxide Eugenol
- All makers of Cement, Dental
- All makers of Agent, Tooth Bonding, Resin
- All makers of Material, Tooth Shade, Resin
- All makers of Condenser, Amalgam And Foil, Operative
- All makers of Pick, Massaging
Updated September 16, 2026. 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.