FDA Registration
Active
🇺🇸 United States
Park Dental Research Corp
Reg #: 3008910197
·
FEI: 3008910197
·
Expires 2026
Products
24
Proprietary Names
34
Establishment Types
4
Classifications
24
Registration Details
- Registration Name
- Park Dental Research Corp
- Registration Number
- 3008910197
- FEI Number
- 3008910197
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2401 N Commerce St Ste E
- City
- Ardmore
- State
- OK
- ZIP
- 73401
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111290
Owner / Operator
- Firm Name
- Park Dental Research Corp
- Operator Number
- 10035707
- Address
- 2401 N Commerce Suite E
- City
- Ardmore
- State
- OK
- Postal Code
- 73401
- Country
- US
- Correspondent
- Senthil Sampath
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2023-04-19 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2018-11-13 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2018-11-13 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2014-10-21 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2014-10-21 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2018-11-13 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2014-10-21 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2013-06-26 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2011-03-17 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2018-11-13 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2021-11-12 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2021-11-12 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2022-07-08 |
| Barrier, Animal Source, Intraoral | NPL | Class 2 | Dental | No | 2014-10-21 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2021-11-12 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2021-11-12 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2021-11-12 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 2019-05-14 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2014-10-21 |
| Eraser, Dental Stain | MAU | Class 1 | Dental | No | 2021-11-12 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2018-11-13 |
| Bone Grafting Material, Animal Source | NPM | Class 2 | Dental | No | 2014-10-21 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2018-11-13 |
| Orthodontic Software | PNN | Class 2 | Dental | No | 2022-11-23 |
Proprietary Names
Volo DigiLine23
NR Piezo
Juell 3D Volo
Juell 3D Micro Volo
Juell 3D VoloCast
Juell 3D Micro VoloCast
JuellCure Hard Impression Material
JuellCure Hard
StarGraft Granules
LEW Mini O-Ball Implant
StarVent
LEW
Dental impression material
Teeth Whitening Light; Teeth whitening Led Light; Portable Teeth Whitening Light;; ProLite LED Teeth Whitening Device
Six Month Smiles Aligners
StarMem
Cheek Retractor/Mouth Opener/Lip Retractor
Thermoplastic Mouth Tray/Mouth Piece/Teeth Whitening Mouth Tray/Foam Strip Mouth Tray/Gel Prefilled Mouth Tray
Denture Cleansing Tablet
DigiLine
Clear Moves
StarDerm
Orthodontic Accelerator
Park Dental Research Aligners
STARTANIUS DENTAL IMPLANT SYSTEM
JuellCure Soft Impression Material
JuellCure Soft
StarVent Internal Hex Screw Implant Abutments
StarVent Internal Hex Screw Implant
Remineralization Gel/Desensitizing Gel/Teeth Whitening Kit/Teeth Whitening Home Kit/Teeth Whitening System
Bone Collector System
StarGraft Putty
Magnetic Mallet
Orchestrate 3D
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)