On1 Universal Abutment
K-Number: K181869 · 2018-12-12
ApplicantNobel Biocare AB
Decision Date2018-12-12
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
On1 Universal Abutment is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2018-12-12 under approval number K181869. 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 On1 Universal Abutment?
On1 Universal Abutment is a medical device that received FDA 510(k) clearance on 2018-12-12. It is manufactured by Nobel Biocare AB. The 510(k) number is K181869.
When was On1 Universal Abutment approved by the FDA?
On1 Universal Abutment received FDA 510(k) clearance on 2018-12-12, under approval number K181869.
What company makes On1 Universal Abutment?
On1 Universal Abutment is manufactured by Nobel Biocare AB.
What is the FDA product code for On1 Universal Abutment?
The FDA product code for On1 Universal Abutment 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.