On1 Concept
K-Number: K161655 · 2017-02-28
ApplicantNobel Biocare AB
Decision Date2017-02-28
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
On1 Concept is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2017-02-28 under approval number K161655. 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 Concept?
On1 Concept is a medical device that received FDA 510(k) clearance on 2017-02-28. It is manufactured by Nobel Biocare AB. The 510(k) number is K161655.
When was On1 Concept approved by the FDA?
On1 Concept received FDA 510(k) clearance on 2017-02-28, under approval number K161655.
What company makes On1 Concept?
On1 Concept is manufactured by Nobel Biocare AB.
What is the FDA product code for On1 Concept?
The FDA product code for On1 Concept is NHA.
Other Devices by Nobel Biocare AB
Related Devices (Code: NHA)
K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.
K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG
K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A.
K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.
K161435Temporary Snap AbutmentNobel Biocare AB
K160786RODO Abutment SystemRodo Medical, Inc.
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.