Tetric PowerFill
K-Number: K183380 · 2019-03-14
ApplicantIvoclar Vivadent, AG
Decision Date2019-03-14
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Tetric PowerFill is a medical device manufactured by Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2019-03-14 under approval number K183380. 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 Tetric PowerFill?
Tetric PowerFill is a medical device that received FDA 510(k) clearance on 2019-03-14. It is manufactured by Ivoclar Vivadent, AG. The 510(k) number is K183380.
When was Tetric PowerFill approved by the FDA?
Tetric PowerFill received FDA 510(k) clearance on 2019-03-14, under approval number K183380.
What company makes Tetric PowerFill?
Tetric PowerFill is manufactured by Ivoclar Vivadent, AG.
What is the FDA product code for Tetric PowerFill?
The FDA product code for Tetric PowerFill 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.