CEREC Tessera Abutment Block, CEREC Tessera Abutment System
K-Number: K221402 · 2023-03-22
ApplicantDentsply Sirona, Inc.
Decision Date2023-03-22
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
CEREC Tessera Abutment Block, CEREC Tessera Abutment System is a medical device manufactured by Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2023-03-22 under approval number K221402. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CEREC Tessera Abutment Block, CEREC Tessera Abutment System?
CEREC Tessera Abutment Block, CEREC Tessera Abutment System is a medical device that received FDA 510(k) clearance on 2023-03-22. It is manufactured by Dentsply Sirona, Inc.. The 510(k) number is K221402.
When was CEREC Tessera Abutment Block, CEREC Tessera Abutment System approved by the FDA?
CEREC Tessera Abutment Block, CEREC Tessera Abutment System received FDA 510(k) clearance on 2023-03-22, under approval number K221402.
What company makes CEREC Tessera Abutment Block, CEREC Tessera Abutment System?
CEREC Tessera Abutment Block, CEREC Tessera Abutment System is manufactured by Dentsply Sirona, Inc..
What is the FDA product code for CEREC Tessera Abutment Block, CEREC Tessera Abutment System?
The FDA product code for CEREC Tessera Abutment Block, CEREC Tessera Abutment System is NHA.
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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.