FDA 510(k)

AvaDent Denture Base Material

K-Number: K153590 · 2016-04-22

Decision Date2016-04-22

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

AvaDent Denture Base Material is a medical device manufactured by Global Dental Science. It received FDA 510(k) clearance on 2016-04-22 under approval number K153590. 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 AvaDent Denture Base Material?

AvaDent Denture Base Material is a medical device that received FDA 510(k) clearance on 2016-04-22. It is manufactured by Global Dental Science. The 510(k) number is K153590.

When was AvaDent Denture Base Material approved by the FDA?

AvaDent Denture Base Material received FDA 510(k) clearance on 2016-04-22, under approval number K153590.

What company makes AvaDent Denture Base Material?

AvaDent Denture Base Material is manufactured by Global Dental Science.

What is the FDA product code for AvaDent Denture Base Material?

The FDA product code for AvaDent Denture Base Material is EBI.

Related Clinical Trials

NCT07608211 Development of a Sanitizing Tablet for Removable Partial Dentures NOT_YET_RECRUITING

Related Devices (Code: EBI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.