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Data / Medical devices / United States / Park Dental Research Corp

Park Dental Research Corp: FDA-registered device maker in Ardmore, OK, United States, 16 510(k) clearances

Park Dental Research Corp is registered with the FDA (registration 3008910197) in Ardmore, OK, United States. It lists 24 device types. The FDA files 16 510(k) clearances under its listings, the newest dated April 5, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number
3008910197
Address
2401 N Commerce St Ste E, Ardmore, OK, United States, 73401
Owner or operator
Park Dental Research Corp (10035707)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
March 17, 2011
Registered through
2026
Brand names listed
Bone Collector System, Cheek Retractor/Mouth Opener/Lip Retractor, Clear Moves, Dental impression material, Denture Cleansing Tablet, DigiLine, Juell 3D Micro Volo, Juell 3D Micro VoloCast and more

Devices it lists

DeviceProduct codeClassRoleSource
Abutment, Implant, Dental, EndosseousNHA2Manufacturer, Specification developeraccessdata.fda.gov
Accessories, Implant, Dental, EndosseousNDP1Manufactureraccessdata.fda.gov
Aligner, SequentialNXC2Contract manufacturer, Manufactureraccessdata.fda.gov
Barrier, Animal Source, IntraoralNPL2Repackager or relabeleraccessdata.fda.gov
Bone Grafting Material, Animal SourceNPM2Repackager or relabeleraccessdata.fda.gov
Bone Grafting Material, SyntheticLYC2Repackager or relabeleraccessdata.fda.gov
Cleanser, Denture, Over The CounterEFT1Repackager or relabeleraccessdata.fda.gov
Drill, Bone, PoweredDZI2Repackager or relabeleraccessdata.fda.gov
Eraser, Dental StainMAU1Repackager or relabeleraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Repackager or relabeleraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Repackager or relabeleraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Repackager or relabeleraccessdata.fda.gov
Heat Source For Bleaching TeethEEG1Repackager or relabeleraccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Manufacturer, Specification developeraccessdata.fda.gov
Instruments, Dental HandDZN1Manufacturer, Specification developeraccessdata.fda.gov
Maintainer, Space Preformed, OrthodonticDYT1Manufactureraccessdata.fda.gov
Motor, Surgical Instrument, Ac-PoweredGEY1Repackager or relabeleraccessdata.fda.gov
Orthodontic SoftwarePNN2Manufactureraccessdata.fda.gov
Resin, Denture, Relining, Repairing, RebasingEBI2Repackager or relabeleraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeleraccessdata.fda.gov
Scaler, UltrasonicELC2Repackager or relabeleraccessdata.fda.gov
Setter, Band, OrthodonticECR1Repackager or relabeleraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 5, 2024K233935DigiLine Direct Print Aligner SystemNXCSubstantially EquivalentPark Dental Research Corporationaccessdata.fda.gov
January 8, 2019K180648Park Dental Research AlignersNXCSubstantially EquivalentPark Dental Research Corporationaccessdata.fda.gov
November 26, 2018K181112Orchestrate 3DPNNSubstantially EquivalentOrchestrate 3Daccessdata.fda.gov
September 24, 2012K121707LEW MDI O-BALL COLLARED IMPLANT,DZESubstantially EquivalentPark Dental Research Corp.accessdata.fda.gov
November 18, 2011K111290PIEZO BONE SURGERYDZISubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
September 12, 2011K111178JUELL SOFT CUREEBISubstantially EquivalentJuell Dentalaccessdata.fda.gov
September 12, 2011K111177JUELL HARD CUREEBISubstantially EquivalentJuell Dentalaccessdata.fda.gov
July 29, 2011K110600COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGENNPLSubstantially EquivalentCollagen Matrix, Inc.accessdata.fda.gov
July 29, 2011K110548OSI O-BALL ABUTMENT HEAD IMPLANTSDZESubstantially EquivalentJuell Dentalaccessdata.fda.gov
February 28, 2011K103399GENERAL DENISTRY MOTOREKXSubstantially EquivalentAseptico, Inc.accessdata.fda.gov
August 26, 2010K082800STAR/VENT INTERNAL HEX SCREW IMPLANTDZESubstantially EquivalentPark Dental Research Corp.accessdata.fda.gov
February 12, 2009K083742SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIXLYCSubstantially EquivalentCollagen Matrix, Inc.accessdata.fda.gov
October 18, 2007K072397SYNOSS SYNTHETIC BONE GRAFT MATERIALLYCSubstantially EquivalentCollagen Matrix, Inc.accessdata.fda.gov
October 13, 2006K062846COLLAGEN DENTAL MEMBRANE IIINPLSubstantially EquivalentCollagen Matrix, Inc.accessdata.fda.gov
May 3, 2005K051077E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101EGSSubstantially EquivalentAseptico, Inc.accessdata.fda.gov
March 6, 1986K854749STARTANIUS DENTAL IMPLANT SYSTEMDZESubstantially EquivalentPark Dental Research Corp.accessdata.fda.gov

Compare with other makers

Updated April 5, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.