Denture Base Polymers
K-Number: K220680 · 2022-08-12
Decision Date2022-08-12
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Denture Base Polymers is a medical device manufactured by Shandong Huge Dental Material Corporation. It received FDA 510(k) clearance on 2022-08-12 under approval number K220680. 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 Denture Base Polymers?
Denture Base Polymers is a medical device that received FDA 510(k) clearance on 2022-08-12. It is manufactured by Shandong Huge Dental Material Corporation. The 510(k) number is K220680.
When was Denture Base Polymers approved by the FDA?
Denture Base Polymers received FDA 510(k) clearance on 2022-08-12, under approval number K220680.
What company makes Denture Base Polymers?
Denture Base Polymers is manufactured by Shandong Huge Dental Material Corporation.
What is the FDA product code for Denture Base Polymers?
The FDA product code for Denture Base Polymers is EBI.
Other Devices by Shandong Huge Dental Material 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.