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
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 5, 2024 | K233935 | DigiLine Direct Print Aligner System | NXC | Substantially Equivalent | Park Dental Research Corporation | accessdata.fda.gov |
| January 8, 2019 | K180648 | Park Dental Research Aligners | NXC | Substantially Equivalent | Park Dental Research Corporation | accessdata.fda.gov |
| November 26, 2018 | K181112 | Orchestrate 3D | PNN | Substantially Equivalent | Orchestrate 3D | accessdata.fda.gov |
| September 24, 2012 | K121707 | LEW MDI O-BALL COLLARED IMPLANT, | DZE | Substantially Equivalent | Park Dental Research Corp. | accessdata.fda.gov |
| November 18, 2011 | K111290 | PIEZO BONE SURGERY | DZI | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| September 12, 2011 | K111178 | JUELL SOFT CURE | EBI | Substantially Equivalent | Juell Dental | accessdata.fda.gov |
| September 12, 2011 | K111177 | JUELL HARD CURE | EBI | Substantially Equivalent | Juell Dental | accessdata.fda.gov |
| July 29, 2011 | K110600 | COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| July 29, 2011 | K110548 | OSI O-BALL ABUTMENT HEAD IMPLANTS | DZE | Substantially Equivalent | Juell Dental | accessdata.fda.gov |
| February 28, 2011 | K103399 | GENERAL DENISTRY MOTOR | EKX | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| August 26, 2010 | K082800 | STAR/VENT INTERNAL HEX SCREW IMPLANT | DZE | Substantially Equivalent | Park Dental Research Corp. | accessdata.fda.gov |
| February 12, 2009 | K083742 | SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX | LYC | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| October 18, 2007 | K072397 | SYNOSS SYNTHETIC BONE GRAFT MATERIAL | LYC | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| October 13, 2006 | K062846 | COLLAGEN DENTAL MEMBRANE III | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| May 3, 2005 | K051077 | E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 | EGS | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| March 6, 1986 | K854749 | STARTANIUS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Park Dental Research Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Bone Grafting Material, Synthetic
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Handpiece, Direct Drive, Ac-Powered
- All makers of Setter, Band, Orthodontic
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.