ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA
K-Number: K200676 · 2020-07-08
ApplicantZirkonzahn Srl
Decision Date2020-07-08
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA is a medical device manufactured by Zirkonzahn Srl. It received FDA 510(k) clearance on 2020-07-08 under approval number K200676. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA?
ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA is a medical device that received FDA 510(k) clearance on 2020-07-08. It is manufactured by Zirkonzahn Srl. The 510(k) number is K200676.
When was ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA approved by the FDA?
ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA received FDA 510(k) clearance on 2020-07-08, under approval number K200676.
What company makes ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA?
ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA is manufactured by Zirkonzahn Srl.
What is the FDA product code for ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA?
The FDA product code for ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA is EBG.
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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.