FDA Registration
Active
🇨🇦 Canada
DIADENT GROUP INTL., INC.
Reg #: 9615399
·
FEI: 3002574147
·
Expires 2026
Products
24
Proprietary Names
54
Establishment Types
3
Classifications
24
Registration Details
- Registration Name
- DIADENT GROUP INTL., INC.
- Registration Number
- 9615399
- FEI Number
- 3002574147
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 380-8210 Ross Street
- City
- Vancouver British Columbia
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K182009
Owner / Operator
- Firm Name
- DIADENT GROUP INTL., INC.
- Operator Number
- 9035015
- Address
- 380-8210 Ross Street, --
- City
- Vancouver
- State
- British Columbia
- Postal Code
- V5X 0L1
- Country
- CA
US Agent
- Business Name
- USDeviceAgent.com
- Contact Name
- Jim MacNee
- Address
- 31574 Flying Cloud Drive
- City
- Laguna Niguel
- State
- CA
- ZIP
- 92677
- Country
- US
- [email protected]
- Phone
- 951 8486626
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2003-09-02 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2019-04-09 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2019-09-26 |
| Tip, Rubber, Oral Hygiene | JEW | Class 1 | Dental | No | 2019-04-09 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2020-03-25 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2022-03-29 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2019-04-09 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2020-02-13 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2023-02-19 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2003-09-02 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2003-07-29 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2020-02-13 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2003-09-02 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2023-10-11 |
| Broach, Endodontic | EKW | Class 1 | Dental | No | 2003-09-02 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 1998-09-10 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2003-09-02 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2019-06-13 |
| Preparer, Root Canal Endodontic | EKQ | Class 1 | Dental | No | 2005-10-04 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2020-09-02 |
| Condenser, Amalgam And Foil, Operative | EKG | Class 1 | Dental | No | 2019-04-09 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2019-04-09 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2003-09-02 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2003-09-02 |
Proprietary Names
Miracle Suction
DIA-ENDORING
ENDO STOPS DIRECTIONAL ASST
FILE MEASURE SET
Endo Training Blocks
Endo Shaping Blocks
DIA-GP GAUGE
DIA-PROSEAL
Irrigation Tips (End Open Type)
Steri. Irrigation Tips (Side Open Type)
Disposable Tips
DIAFIL FLOW
DiaCemTempNE
Disposable Brushes
DiaTemp Flow
Dia-Ultrasonic
GUTTA PERCHA POINTS
GUTTA PERCHA OBTURATOR
DIA-ROOT BIO MTA
Dia-100FS
DIAETCH
H-FILE (NICKEL-TITANIUM)
K-FILE (NICKEL-TITANIUM)
K-Files
Reamers
Hedstrom Files
REAMER (NICKEL-TITANIUM)
DIAFIL Bulk FLOW
Dia-Cem
Barbed Broaches
DIA-X BOND Universal
DiaTemp
DIAFIL
DIAFIL Capsule Type
DiaFlex
Dia-Duo
Duo-Pen
Duo-Gun
DIAFIL START KIT
DIA-ROOT BIO Sealer
DiaPex Plus
Brush Handle
Mixing Well
Mixing pad
Brush Tips
DiaPrep Pro
D-Lux+
DIA-KONDENSOR
Peeso Reamers
Gate Drills
ABSORBENT PAPER POINTS(Sterile Paper Points)
DiaPaste
Cheek Retractors
DiaPlus
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Foreign Private Label Distributor
Repack or Relabel Medical Device