Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007728269

FEI Number

3007728269

Entity Name

Digital Dental Laboratories, DBA Orthodent

City/State/Country

Oshawa Ontario, CA

Establishment Address

311 Viola St., Oshawa Ontario L1H 3A7, CA

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Digital Dental Laboratories, Inc. DBA Orthodent (Owner Number: 10028965)

Owner / Operator Contact Address

311 Viola St., Oshawa, CA-ON L1H 3A7, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ON1 Alf appliance Quad helix - fixed Quad Helix Hor Rem Porter Arch - Vert Rem ON4 ON3 OD1 ON2 Nance - Hor Rem Perfector ON5 OD3 Pk1 Biofinisher Habit breaker - removable Quad helix Lingual Arch - Hor rem OD4 Linguarl Arch - Vert Rem Homeoblock Porter Arch - Hor Rem Quad Helix - Vert Rem Lingual Arch - Soldered OD2 Bionator/Activator Nance - Vert Rem Nance - soldered Adapt Appliance Porter arch - soldered 3-way saggital Pro-adapter appliance Fraenkel Finish Full Denture Set Full Denture Anterior Remodelling Appliance Molar Tubes EAS MJX 2000 Molar uprighter jet Pendulum Appliance TPA - fixed Transforce transverse Distal Jet 2 Bands Fisher tad molar destabilizer MSX 2000 Tpa with acrylic pads Fixed retaining appliances - cd distalizer Rick-an-ator RPE - Compact Complete Appliance Exspider appliance Pedo Denture Sag 2000 Halterman appliance Habit breaking appliances - banded hyrax with crib SAL 2000 SAN 2000 Mora appliance Max 2000 Farrari 1 Exspider Appliance with Acrylic Pads CS 2000 Exspider Appliance 2 Bands RPE - Compance Complete Appliance MSC 2000 MJX 2000 Super Screw Appliance w Bands Mara/M2M Appliance Herbst appliance TB Sag 2000 Galella Tongue Bead Appliance Lip Bumper with 2 hooks Distal Jet 4 Bands RPE - Compact with Acrylic Pads Fixed retaining appliances - rpe Dmax 2000 DMJ 2000 Rick-an-ator - fixed RPE with Memory Expander Habit breaking appliances - galella tongue bead appliance Tad Appliance Lingual Arch - Hor. Rem. Dmax/RPE 2000 Transforce sagittal RPE with 2 bands Lip Bumper on Appliance RPE with Acrylic Pads Distal jet Habit Breaker - Fixed Splint - Damon Night Appliance RPE with Veltri Screw HAAS Appliance with Bands Fisher tad holding appliance Distal jet complete Fisher tad expansion appliance Herbst Appliance with bands Niti expander Habit breaking appliances - limp bumper EAS MSX 2000 TPA - hor rem TPA - Vert rem Tandem traction appliance EAS MSC 2000 Rpe - compact RPE with 4 bands Haas appliance Lip bumper Intra aveloar space maintainer Rpe Bracket Inovation R Positioned Bracket Inovation R Bracket 5-5 Inovation R Brackets 6-6 Mini Twin

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2024-12-19
NSL	Dentures, Full	Unknown	Class N	N/A	2024-12-19
NSR	Prosthesis, Orthodontic	Unknown	Class N	N/A	2024-12-19
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2011-07-29
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2024-12-19
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2011-07-29

Official Correspondent

Lori Way

US Agent Details

Carlos Ortiz Business: C ortiz independent consultant LLC Email: ortiz.carlos.a@hotmail.com Phone: (770) 7133630

Related Public Records

Same Entity

Digital Dental Laboratories, Inc. DBA Orthodent

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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007728269. Last updated year: 2026. Please use registration number 3007728269 when referencing this establishment in official correspondence.