Manufacturer registered with FDA
Park Dental Research Corp
Ardmore, OK, United States. Lists 23 dental device types with FDA across 1 registered establishment, and holds 8 510(k) clearances as applicant.
- Device types listed
- 23
- Brands and models
- 37
- 510(k) clearances
- 81986–2026
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1980–2026
Registered in 3 markets
Where regulators' registries name Park Dental Research Corp as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Park Dental Research Corp | 8 clearances | 1986–2026 | Below |
| Israel | AMAR | Manufacturer | Park Dental Research CorpPark Dental Research Corporation | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | PARK DENTAL RESEARCH CORP | 1 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Park Dental Research Corp currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | LEW Mini O-Ball ImplantSTARTANIUS DENTAL IMPLANT SYSTEMStarVent Internal Hex Screw ImplantStarVent Internal Hex Screw Implant Abutments | 2013 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Clear MovesDigiLinePark Dental Research AlignersSix Month Smiles Aligners | 2019 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | JuellCure HardJuellCure Hard Impression MaterialJuellCure SoftJuellCure Soft Impression Material | 2014 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Lister | StarGraft GranulesStarGraft Putty | 2014 |
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Lister | StarDermStarMem | 2014 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Volo DigiLine23 | 2023 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Lister | NR Piezo | 2018 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | LEWStarVent | 2011 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Lister | Orthodontic Accelerator | 2019 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Lister | Teeth Whitening Light; Teeth whitening Led Light; Portable Teeth Whitening Light;; ProLite LED Teeth Whitening Device | 2021 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Lister | Denture Cleansing Tablet | 2021 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | — | 2018 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Thermoplastic Mouth Tray/Mouth Piece/Teeth Whitening Mouth Tray/Foam Strip Mouth Tray/Gel Prefilled Mouth Tray | 2021 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Lister | Bone Collector System | 2018 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | Dental impression material | 2021 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | Cheek Retractor/Mouth Opener/Lip Retractor | 2021 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | — | 2018 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | NR Piezo | 2018 |
| Dental Stain EraserMAU · Class 1 | — | Lister | Remineralization Gel/Desensitizing Gel/Teeth Whitening Kit/Teeth Whitening Home Kit/Teeth Whitening System | 2021 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Juell 3D Micro VoloJuell 3D Micro VoloCastJuell 3D VoloJuell 3D VoloCast | 2014 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | StarVent Internal Hex Screw ImplantStarVent Internal Hex Screw Implant Abutments | 2014 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Lister | StarGraft Putty | 2014 |
| Orthodontic SoftwarePNN · Class 2 | Dental design & orthodontic software | Maker | Orchestrate 3D | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Park Dental Research Corp as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 20 Oct 2026 | K262937 | PDR Airway Device | LRK Anti-Snoring Device |
| 18 Dec 2025 | K252976 | Park Dental Nylon MAD | LRK Anti-Snoring Device |
| 5 Apr 2024 | K233935 | DigiLine Direct Print Aligner System | NXC Sequential Aligner |
| 8 Jan 2019 | K180648 | Park Dental Research Aligners | NXC Sequential Aligner |
| 12 Oct 2018 | K181220 | Juell 3D Volo Base | EBI Rebasing Repairing Relining Denture Resin |
| 24 Sep 2012 | K121707 | LEW MDI O-BALL COLLARED IMPLANT, | DZE Root-Form Endosseous Implant |
| 26 Aug 2010 | K082800 | STAR/VENT INTERNAL HEX SCREW IMPLANT | DZE Root-Form Endosseous Implant |
| 6 Mar 1986 | K854749 | STARTANIUS DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Sleepcare, LLC (1), Selane Products, Inc. (1).
Also lists devices cleared under other names
Park Dental Research Corp 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: Collagen Matrix, Inc. (4), Juell Dental (3), Aseptico, Inc. (2), Orchestrate 3D (1), Guilin Woodpecker Medical Instrument Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 26 Nov 2018 | K181112 | Orchestrate 3D | Orchestrate 3D | PNN Orthodontic Software |
| 18 Nov 2011 | K111290 | PIEZO BONE SURGERY | Guilin Woodpecker Medical Instrument Co., Ltd. | DZI Powered Bone Drill |
| 12 Sep 2011 | K111178 | JUELL SOFT CURE | Juell Dental | EBI Rebasing Repairing Relining Denture Resin |
| 12 Sep 2011 | K111177 | JUELL HARD CURE | Juell Dental | EBI Rebasing Repairing Relining Denture Resin |
| 29 Jul 2011 | K110548 | OSI O-BALL ABUTMENT HEAD IMPLANTS | Juell Dental | DZE Root-Form Endosseous Implant |
| 29 Jul 2011 | K110600 | COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN | Collagen Matrix, Inc. | NPL Intraoral Animal Source Barrier |
| 28 Feb 2011 | K103399 | GENERAL DENISTRY MOTOR | Aseptico, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 12 Feb 2009 | K083742 | SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX | Collagen Matrix, Inc. | LYC Synthetic Bone Grafting Material |
| 18 Oct 2007 | K072397 | SYNOSS SYNTHETIC BONE GRAFT MATERIAL | Collagen Matrix, Inc. | LYC Synthetic Bone Grafting Material |
| 13 Oct 2006 | K062846 | COLLAGEN DENTAL MEMBRANE III | Collagen Matrix, Inc. | NPL Intraoral Animal Source Barrier |
| 3 May 2005 | K051077 | E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 | Aseptico, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Park Dental Research CorpFDA reg. 3008910197 | Ardmore, OK, United States | Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10035707). 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.