Manufacturer registered with FDA
Digital Dental Laboratories, Inc. DBA Orthodent
Oshawa, Canada. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 169
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Canada
Devices listed with FDA
What Digital Dental Laboratories, Inc. DBA Orthodent currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Bihelix - RemovableBite Plate with 2 Adams ClaspsBite Plate with 4 Ball ClaspsBowbeer ApplianceDaytime ApplicanceInman Spring AlignerRetainer - 3 to 3 no meshRetainer - 3 to 3 with meshRetainer - 6 Acrylic PadsRetainer - 6 mesh pads 10 moreRetainer - essexRetainer - Lower ClipRetainer - SolderedRetainer - UnsolderedRetainer - WrapRetainer Soldered - QCM ArchRetainer with Mushroom SpringSuper Spring Speed AlignerTwin Block ApplianceUpper and Lower Saggital | 2011 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Band loop space maintainerBand loop space regainerBihelix - solderedCrozat crib and crescentMarangos tripod splintMonoblockOrthopedic correctorOrthotic - splintsPositionerSplint - "B" 30 moreSplint - 2 "C" ClaspsSplint - 2 Adams ClaspsSplint - 2 Ball ClaspsSplint - 2 Ball Clasps/AcetalSplint - 4 Ball ClaspsSplint - Anterior DeprogrammerSplint - BiocrylSplint - BruxeezeSplint - Compact Day ApplianceSplint - Damon Night ApplianceSplint - Day Positioned ApplianceSplint - Day Positioned/AcetalSplint - DualSplint - EclipseSplint - ErkolocSplint - Erkoloc ProSplint - FarrarSplint - FlexiteSplint - GelbSplint - Koise DeprogrammerSplint - LucoSplint - MapaSplint - Night ApplianceSplint - Night Appliance with Nasal DialatorSplint - no claspsSplint - NTISplint - Pivot ApplianceSplint - RemedeezeSplint - SVED/Rick-a-natorSplint - Witzig/Denar | 2024 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Lister | Molar Tubes | 2011 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Adapt ApplianceAlf applianceBiofinisherBionator/ActivatorFraenkelHabit breaker - removableHomeoblockLingual Arch - Hor remLingual Arch - SolderedLinguarl Arch - Vert Rem 23 moreNance - Hor RemNance - solderedNance - Vert RemOD1OD2OD3OD4ON1ON2ON3ON4ON5PerfectorPk1Porter Arch - Hor RemPorter arch - solderedPorter Arch - Vert RemPro-adapter applianceQuad helixQuad helix - fixedQuad Helix - Vert RemQuad Helix Hor Rem3-way saggital | 2024 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | CS 2000Distal jetDistal Jet 2 BandsDistal Jet 4 BandsDistal jet completeDmax 2000Dmax/RPE 2000DMJ 2000EAS MJX 2000EAS MSC 2000 61 moreEAS MSX 2000Exspider applianceExspider Appliance 2 BandsExspider Appliance with Acrylic PadsFarrari 1Fisher tad expansion applianceFisher tad holding applianceFisher tad molar destabilizerFixed retaining appliances - cd distalizerFixed retaining appliances - rpeGalella Tongue Bead ApplianceHaas applianceHAAS Appliance with BandsHabit Breaker - FixedHabit breaking appliances - banded hyrax with cribHabit breaking appliances - galella tongue bead applianceHabit breaking appliances - limp bumperHalterman applianceHerbst applianceHerbst Appliance with bandsIntra aveloar space maintainerLingual Arch - Hor. Rem.Lip bumperLip Bumper on ApplianceLip Bumper with 2 hooksMara/M2M ApplianceMax 2000MJX 2000Molar uprighter jetMora applianceMSC 2000MSX 2000Niti expanderPedo DenturePendulum ApplianceRick-an-atorRick-an-ator - fixedRpeRpe - compactRPE - Compact Complete ApplianceRPE - Compact with Acrylic PadsRPE - Compance Complete ApplianceRPE with 2 bandsRPE with 4 bandsRPE with Acrylic PadsRPE with Memory ExpanderRPE with Veltri ScrewSag 2000SAL 2000SAN 2000Splint - Damon Night ApplianceSuper Screw Appliance w BandsTad ApplianceTandem traction applianceTB Sag 2000TPA - fixedTPA - hor remTPA - Vert remTpa with acrylic padsTransforce sagittalTransforce transverse | 2024 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | Bracket 5-5 Inovation RBracket Inovation RBracket Inovation R PositionedBrackets 6-6 Mini Twin | 2011 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Digital Dental Laboratories, DBA OrthodentFDA reg. 3007728269 | Oshawa Ontario, Canada | Manufacturer, Repacker / relabeler |
Other names on FDA records
Digital Dental Laboratories, DBA Orthodent
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028965). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.