Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615291

FEI Number

3001003585

Entity Name

AURUM CERAMIC DENTAL LABORATORIES LTD.

City/State/Country

CALGARY Alberta, CA

Establishment Address

115-17TH AVE., S.W., CALGARY Alberta T2S 0A1, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AURUM GROUP LTD. (Owner Number: 9031158)

Owner / Operator Contact Address

115-17TH AVE., S.W., --, CALGARY, AB, CA-AB T2S 0A1, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Snoring device Custom Tray DNA ORTHODONTIC APPLIANCE denture TEETH POSITIONER ORTHODONTIC APPLIANCE AurumGroup Bleaching tray DENTAL PROSTHESIS CROWN DENTAL PROSTHESIS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LQZ	Device, Jaw Repositioning	Dental	Class 2	872.5570	2022-02-01
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2022-02-01
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2008-08-15
LQZ	Device, Jaw Repositioning	Dental	Class 2	872.5570	2023-09-21
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2023-09-21
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2006-04-25
NSL	Dentures, Full	Unknown	Class N	N/A	2012-03-28
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2004-05-06
EJP	Articulators	Dental	Class 1	872.3150	2018-03-16
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2008-08-15
ELJ	Teeth, Artificial, Posterior With Metal Insert	Dental	Class 1	872.3900	2006-05-16
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2004-05-06

Official Correspondent

James Lee

US Agent Details

Debbie Authier Email: debbiem@aurumgroup.com Phone: (509) 3265885

Related Public Records

Same Entity

AURUM GROUP LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3031799	AURUM CERAMIC DENTAL LABORATORIES LLC	SPOKANE, WA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615291. Last updated year: 2026. Please use registration number 9615291 when referencing this establishment in official correspondence.