Juell 3D Volo Base
K-Number: K181220 · 2018-10-12
ApplicantPark Dental Research Corporation
Decision Date2018-10-12
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Juell 3D Volo Base is a medical device manufactured by Park Dental Research Corporation. It received FDA 510(k) clearance on 2018-10-12 under approval number K181220. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Juell 3D Volo Base?
Juell 3D Volo Base is a medical device that received FDA 510(k) clearance on 2018-10-12. It is manufactured by Park Dental Research Corporation. The 510(k) number is K181220.
When was Juell 3D Volo Base approved by the FDA?
Juell 3D Volo Base received FDA 510(k) clearance on 2018-10-12, under approval number K181220.
What company makes Juell 3D Volo Base?
Juell 3D Volo Base is manufactured by Park Dental Research Corporation.
What is the FDA product code for Juell 3D Volo Base?
The FDA product code for Juell 3D Volo Base is EBI.
Other Devices by Park Dental Research Corporation
Related Devices (Code: EBI)
K161330Pour AcrylicDentsply Sirona
K153546PINK CAD/CAM discPolident D.O.O., Dental Products Industry
K152981JET SET 4 DENTURE REPAIR RESINLang Dental Manufacturing Company, Inc.
K160498Dentivera Milling DiscDental Solutions, LLC
K153590AvaDent Denture Base MaterialGlobal Dental Science
K152051ClearMetMycone Dental Supply Co., T/A Keystone Industries
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.