FDA Registration
Active
🇨🇦 Canada
Digital Dental Laboratories, DBA Orthodent
Reg #: 3007728269
·
FEI: 3007728269
·
Expires 2026
Products
9
Proprietary Names
187
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- Digital Dental Laboratories, DBA Orthodent
- Registration Number
- 3007728269
- FEI Number
- 3007728269
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 311 Viola St.
- City
- Oshawa Ontario
- Country
- CA
Owner / Operator
- Firm Name
- Digital Dental Laboratories, Inc. DBA Orthodent
- Operator Number
- 10028965
- Address
- 311 Viola St.
- City
- Oshawa
- State
- Ontario
- Postal Code
- L1H 3A7
- Country
- CA
- Correspondent
- Lori Way
US Agent
- Business Name
- C ortiz independent consultant LLC
- Contact Name
- Carlos Ortiz
- Address
- 1525 Victoria St
- City
- Douglasville
- State
- GA
- ZIP
- 30134
- Country
- US
- [email protected]
- Phone
- 770 7133630
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2024-12-19 |
| Dentures, Full | NSL | Class N | Unknown | No | 2024-12-19 |
| Prosthesis, Orthodontic | NSR | Class N | Unknown | No | 2024-12-19 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2011-07-29 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2024-12-19 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2011-07-29 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2011-07-29 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2024-12-19 |
| Dentures, Partial | NSK | Class N | Unknown | No | 2024-12-19 |
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
Retainer - 6 Acrylic Pads
Retainer - essex
Retainer - Unsoldered
Retainer - 6 mesh pads
Retainer with Mushroom Spring
Daytime Applicance
Twin Block Appliance
Retainer - Lower Clip
Retainer - Wrap
Bihelix - Removable
Retainer - Soldered
Bowbeer Appliance
Retainer Soldered - QCM Arch
Bite Plate with 4 Ball Clasps
Bite Plate with 2 Adams Clasps
Inman Spring Aligner
Retainer - 3 to 3 with mesh
Upper and Lower Saggital
Super Spring Speed Aligner
Retainer - 3 to 3 no mesh
Positioner
Splint - Remedeeze
Splint - Night Appliance with Nasal Dialator
Orthotic - splints
Splint - Pivot Appliance
Splint - 2 Adams Clasps
Splint - SVED/Rick-a-nator
Splint - no clasps
Splint - Biocryl
Splint - Luco
Band loop space maintainer
Splint - 2 Ball Clasps/Acetal
Band loop space regainer
Orthopedic corrector
Splint - Day Positioned/Acetal
Splint - Day Positioned Appliance
Splint - Night Appliance
Splint - Bruxeeze
Monoblock
Splint - 2 Ball Clasps
Splint - NTI
Splint - Farrar
Splint - "B"
Splint - 2 "C" Clasps
Marangos tripod splint
Splint - Erkoloc
Crozat crib and crescent
Splint - Witzig/Denar
Splint - Anterior Deprogrammer
Splint - 4 Ball Clasps
Splint - Gelb
Splint - Flexite
Splint - Compact Day Appliance
Splint - Mapa
Splint - Koise Deprogrammer
Splint - Erkoloc Pro
Splint - Eclipse
Splint - Dual
Bihelix - soldered
Casting
Set Denture - 8+ teeth
Flipper - 3+ teeth
Unilateral denture
Finish Denture - 8+ teeth
Framework cast
Set Denture - 4-7 teeth
Finish Denture - 1-3 teeth
Unilateral Denture Teeth Included
Unilateral casting
Custom tray
Acetal unilateral
Framework acetal
Set Denture - 1-3 teeth
Finish Denture - 4-7 teeth
Flipper - 1 to 2 teeth
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device