FORMA Composite (Shade A3D)
K-Number: K240694 · 2024-03-15
ApplicantUltradent Products, Inc.
Decision Date2024-03-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
FORMA Composite (Shade A3D) is a medical device manufactured by Ultradent Products, Inc.. It received FDA 510(k) clearance on 2024-03-15 under approval number K240694. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FORMA Composite (Shade A3D)?
FORMA Composite (Shade A3D) is a medical device that received FDA 510(k) clearance on 2024-03-15. It is manufactured by Ultradent Products, Inc.. The 510(k) number is K240694.
When was FORMA Composite (Shade A3D) approved by the FDA?
FORMA Composite (Shade A3D) received FDA 510(k) clearance on 2024-03-15, under approval number K240694.
What company makes FORMA Composite (Shade A3D)?
FORMA Composite (Shade A3D) is manufactured by Ultradent Products, Inc..
What is the FDA product code for FORMA Composite (Shade A3D)?
The FDA product code for FORMA Composite (Shade A3D) is EBF.
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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.