FDA Registration
Active
🇺🇸 United States
PARKELL, INC.
Reg #: 2411797
·
FEI: 2411797
·
Expires 2026
Products
29
Proprietary Names
3
Establishment Types
4
Classifications
29
Registration Details
- Registration Name
- PARKELL, INC.
- Registration Number
- 2411797
- FEI Number
- 2411797
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 300 EXECUTIVE DR.
- City
- EDGEWOOD
- State
- NY
- ZIP
- 11717
- Country
- US
Regulatory Submissions
- 510(k) Number
- K002195
Owner / Operator
- Firm Name
- Parkell, Inc
- Operator Number
- 10047694
- Address
- 300 Executive Drive
- City
- Edgewood
- State
- NY
- Postal Code
- 11717
- Country
- US
- Correspondent
- Yasily Ogando Roa
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Locator, Root Apex | LQY | Class U | Unknown | No | 2016-10-18 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2016-10-18 |
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2016-10-18 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2016-10-18 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2016-10-18 |
| Material, Impression | ELW | Class 2 | Dental | No | 2016-10-18 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2016-10-18 |
| Coating, Filling Material, Resin | EBD | Class 2 | Dental | No | 2016-10-18 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2021-11-15 |
| Cord, Retraction | MVL | Class U | Unknown | No | 2016-10-18 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2016-10-18 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 2017-04-12 |
| Protector, Silicate | EFX | Class 1 | Dental | No | 2016-10-18 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2016-10-18 |
| Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) | JRS | Class 1 | Clinical Chemistry | No | 2024-12-17 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2016-10-18 |
| Unit, Electrosurgical, And Accessories, Dental | EKZ | Class 2 | Dental | No | 2016-10-18 |
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 2016-10-18 |
| Tester, Pulp | EAT | Class 2 | Dental | No | 2016-10-18 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2016-10-18 |
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 2021-11-15 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2016-10-18 |
| Dispenser, Mercury And/Or Alloy | EHE | Class 1 | Dental | No | 2016-10-18 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 2016-10-18 |
| Articulators | EJP | Class 1 | Dental | No | 2016-10-18 |
| Paper, Articulation | EFH | Class 1 | Dental | No | 2016-10-18 |
| Airbrush | KOJ | Class 2 | Dental | No | 2016-10-18 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2016-10-18 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2016-10-18 |
Proprietary Names
Etch-free
Resin post
Smartemp
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)