TiUltra Implants and Xeal Abutments
K-Number: K202344 · 2020-11-16
ApplicantNobel Biocare AB
Decision Date2020-11-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TiUltra Implants and Xeal Abutments is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2020-11-16 under approval number K202344. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TiUltra Implants and Xeal Abutments?
TiUltra Implants and Xeal Abutments is a medical device that received FDA 510(k) clearance on 2020-11-16. It is manufactured by Nobel Biocare AB. The 510(k) number is K202344.
When was TiUltra Implants and Xeal Abutments approved by the FDA?
TiUltra Implants and Xeal Abutments received FDA 510(k) clearance on 2020-11-16, under approval number K202344.
What company makes TiUltra Implants and Xeal Abutments?
TiUltra Implants and Xeal Abutments is manufactured by Nobel Biocare AB.
What is the FDA product code for TiUltra Implants and Xeal Abutments?
The FDA product code for TiUltra Implants and Xeal Abutments is DZE.
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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.