Parkell, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000003761 FEI 2411797
- Devices
- 858
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- Directa ABSE
What Parkell, Inc. makes
Parkell, Inc. manufactures dental composite resins, single-use diamond dental burs, temporary crown and bridge resins, dentine bonding agents, silicone impression materials, soft professional denture reliners, preformed root canal posts, and ultrasonic dental scaling and debridement systems.
The company's devices are classified as Class I, Class II, and Class IIa, and are listed in the EUDAMED, FDA 510(k), and FDA UDI databases. Parkell, Inc. is based in the United States.
Catalogue
Search and filter all 858 devicesShowing 1-50 of 858
Company details
- EUDAMED SRN
- US-MF-000003761
- FDA FEI number
- 2411797
- DUNS number
- 009900424
- EUDAMED status
- Active
- EUDAMED registered name
- Parkell Inc.
- Registered address
- 300, Executive Drive, 11717, Edgewood, United States
- Website
- www.parkell.com
- yogando@parkell.com
- Phone
- 6312491134
- PRRC contact
- Yasily Ogando
Frequently asked questions
How many devices does PARKELL, INC. have in the registry?
The registry currently lists 858 devices for PARKELL, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list PARKELL, INC.'s devices?
Among its 50 most recently registered devices, PARKELL, INC. has devices listed in FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do PARKELL, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for PARKELL, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from PARKELL, INC. in the registry?
The most recently registered devices listed for PARKELL, INC. include Predicta® D650, Predicta® S651, 20/20™ S575 and HyperFIL® S235SP.