Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615399

FEI Number

3002574147

Entity Name

DIADENT GROUP INTL., INC.

City/State/Country

Vancouver British Columbia, CA

Establishment Address

380-8210 Ross Street, Vancouver British Columbia V5X 0L1, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Foreign Private Label Distributor

Owner / Operator

DIADENT GROUP INTL., INC. (Owner Number: 9035015)

Owner / Operator Contact Address

380-8210 Ross Street, --, Vancouver, CA-BC V5X 0L1, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200809

PMA Number

N/A

All Registered 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+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2003-09-02
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2019-04-09
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2019-09-26
JEW	Tip, Rubber, Oral Hygiene	Dental	Class 1	872.6650	2019-04-09
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-03-25
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2022-03-29
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2019-04-09
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2020-02-13
JET	Pick, Massaging	Dental	Class 1	872.6650	2023-02-19
EKM	Gutta-Percha	Dental	Class 1	872.3850	2003-09-02
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2020-10-05
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2003-07-29
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-02-13
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2020-02-13
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2003-09-02
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2026-05-27
EMA	Cement, Dental	Dental	Class 2	872.3275	2023-10-11
EKW	Broach, Endodontic	Dental	Class 1	872.4565	2003-09-02
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2022-08-08
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2020-02-13
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-03-23
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	1998-09-10
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2003-09-02
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2021-07-29
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2021-07-29
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2020-08-11
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2019-09-26
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2019-06-13
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2005-10-04
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2020-09-02

Official Correspondent

No official correspondent registered.

US Agent Details

Jim MacNee Business: USDeviceAgent.com Email: Jmacnee@USDeviceAgent.com Phone: (951) 8486626

Related Public Records

Same Entity

DIADENT GROUP INTL., INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615399. Last updated year: 2026. Please use registration number 9615399 when referencing this establishment in official correspondence.