Registered with FDA
Ortho Pro Dent LLC
Sarasota, FL, United States. Lists 16 dental device types with FDA across 1 registered establishment.
- Device types listed
- 16
- Brands and models
- 133
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Ortho Pro Dent LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | Chemical Cure Composite Restorative MaterialChemical Cure Composite Restorative Material; Chemical Cure Dentin/Enamel Bonding AdhesiveChemical Cure Dentin/Enamel Bonding AdhesiveCitric AcidCore Build up materialDC Core Build Up MaterialDevon - Paste Porcelain Repair KitDevon Dent Dual Cure Core Build Up ,Selfetch one-step bondingDevon-CoreDevon-Core Dual Cure Core Automix Build Up Material 28 moreDevon-Dent Chemical Core Build Up MaterialDevon-Dent Light Cure Core Build Up MaterialDevon-Dent StainsDevon-GelEtchant GelEtchant LiquidHema DesensitizerHema Desensitizer, Devon Dent Nano-Hybrid Composite refillLight Cure Dentin/Enamel Bonding AdhesiveLight Cure One Step Dentin/Enamel Bonding AdhesiveModelerModifierNano compositePorcelain Etchant GelPorcelain Etchant Gel; Devon - Paste Porcelain Repair Kit; Self Etch Bonding Agent;PrimerSelf Etch Bonding AgentSeparatorSilane Bond EnhancerSilane Bond Enhancer; Surface Sealant; Visible Light Cure Composite Restorative MaterialSurface SealantVisible Light Cure Composite Restorative MaterialVisible Light Cure Flowable CompositeVisible Light Cure Flowable Composite; Visible Light Cure Hybrid CompositeVisible Light Cure Hybrid CompositeVisible Light Cure Micro-Hybrid CompositeVisible Light Cure Micro-Hybrid Composite; Visible Light Cure Nano-Hybrid CompositeVisible Light Cure Nano-Hybrid Composite | 2018 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Lister | acid etch and accessoriesAdhesive bonding systemDevon Bond - light cureDevondent orthodontic Adhesive - light cureDevondent Orthodontic adhesive self bonding - light cureMax-Bond Adhesive light cureMax-Bond Orthodontic adhesive self bonding - light cureOrthodontic Adhesive - No mixOrthodontic Adhesive - one step MixingOrthodontic adhesive Band cement 2 moreOrthodontic adhesive light cureOrthodontic adhesive self bonding - light cure | 2017 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Lister | alpha wire NiTi coatedalpha wire NiTi super elasticalpha wire stainless steel wirealpha wire stainless steel wires coatedalpha wire thermal activated wiresOrthodontic preformed ligature wires , Orthodontic Kobayshi wiresOrthodontic reverse curved wiresOrthodontic spring wires , Open coil , Closed coilOrthodontic stainless steel stranded wiresorthodontic wires 1 moreTMA wires | 2017 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Lister | bondable buccal tubeTrumpax buccal tubeweldable buccal tube | 2017 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | Visible Chemical Cure Pit and FissureVisible Light Cure Pit and Fissure | 2018 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | Ligature chain; Ligature ties; lip bumer tubing; Orthodontic elastomeric; rotation wedges; separators; threadOrthodontic appliance and accessories ,elastomeric modules; Extraoral; Intraoral | 2017 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Lister | Band Plain promax bandscleatsligual sheathorthodontic bandorthodontic band and accessoriespromax bands1st Molar band , 2nd Molar band | 2017 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | orthodontic waxPressure Indicating Gel | 2018 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Lister | Devon- GelDevon-Paste | 2018 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | Bracket accessories; Crimpabal hooks;Crimpabal stopers , lingual buttons; Metal bracket; Orthodontic bracketsSelf max-Selfligating Bracket System MBT slot 18Self max-Selfligating Bracket System MBT slot 22Self max-Selfligating Bracket System Roth slot 18Self max-Selfligating Bracket System Roth slot 22Trax Bracket Micro-Etched MBT slot 18Trax Bracket Micro-Etched MBT slot 22Trax Bracket Micro-Etched Roth slot 18Trax Bracket Micro-Etched Roth slot 22Trax-Plus Bracket Micro-Etched MBT slot 18 7 moreTrax-Plus Bracket Micro-Etched MBT slot 22Trax-Plus Bracket Micro-Etched Roth slot 18Trax-Plus Bracket Micro-Etched Roth slot 22Trax-Plus Mini Twin Bracket MBT slot 18Trax-Plus Mini Twin Bracket MBT slot 22Trax-Plus Mini Twin Bracket Roth slot 18Trax-Plus Mini Twin Bracket Roth slot 22 | 2017 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Lister | Defon- GelRC-CREAMRoot Canal Filling Material | 2018 |
| Preformed CrownELZ · Class 1 | — | Lister | Devon-Crown | 2018 |
| Dental CementEMA · Class 2 | Dental cements | Lister | Automix Dual Cure Luting CementDual Cure Luting CementGlass Ionomer Cement; Glass Ionomer RestorativeLight Cure Glass Ionomer RestorativeNon Eugenol Temporary CementPolycarboxylate CementSurgical CementTemporary CementVisible Light Cure LutingZinc Oxide Eugenol Cement 2 moreZinc Oxide Eugenol Reinforced MaterialZinc Phosphate Cement | 2018 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Lister | angle plier, bird beak plier , three prong plier , jaraback plier , torquing plier male and femaledistal end cutter safety , distal end cutter long handle , dista end flush cutterMax Plier,Orthodontic Pliers , Dista end cutter , hard wire cutter , ligature pin cuttersweingart plier , cinch back plier , Tweezer , bracket posioner , bracket holder , Tube holder | 2017 |
| Dental Stain EraserMAU · Class 1 | — | Lister | devonwhite bleaching , in office bleaching , devonwhite smile , Pro white smile, Pro white bleaching , dental bleachingdevonwhite in office bleaching system | 2025 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Lister | Glace- Crystal Sapphire Bracket System MBT slot 18Glace- Crystal Sapphire Bracket System MBT slot 22Glace- Crystal Sapphire Bracket System Roth slot 18Glace- Crystal Sapphire Bracket System Roth slot 22Orthodontic ceramic bracket with metal slotOrthodontic ceramic bracket.Orthodontic Mono Crystalline Sapphire BracketRannix - ceramic bracket with Metal slot system MBT slot 18Rannix - ceramic bracket with Metal slot system MBT slot 22Rannix - ceramic bracket with Metal slot system Roth slot 18 5 moreRannix - ceramic bracket with Metal slot system Roth slot 22Translex - ceramic bracket system MBT slot 18Translex - ceramic bracket system MBT slot 22Translex - ceramic bracket system Roth slot 18Translex - ceramic bracket system Roth slot 22 | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Ortho Pro Dent LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Prime Dental Manufacturing, Inc. (5), Star Dentech Korea., Corp (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Jan 2012 | K112574 | PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT | Prime Dental Manufacturing, Inc. | EMA Dental Cement |
| 27 May 2009 | K090567 | ORTHODONTIC CERAMIC BRACKET | Star Dentech Korea., Corp | NJM Orthodontic Ceramic Bracket |
| 7 Nov 2002 | K022675 | PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL | Prime Dental Manufacturing, Inc. | EBF Resin Tooth Shade Material |
| 1 Nov 2001 | K012761 | PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT | Prime Dental Manufacturing, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 24 Oct 2001 | K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | Prime Dental Manufacturing, Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 30 May 2000 | K001108 | PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL | Prime Dental Manufacturing, Inc. | EBF Resin Tooth Shade Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Ortho Pro Dent LLCFDA reg. 3013410675 | Sarasota, FL, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053964). 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.