Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ATLANTIS Abutment for NobelActive 3.0

K-Number: K151039 · 2016-01-14

ApplicantDentsply International, Inc.
Decision Date2016-01-14
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATLANTIS Abutment for NobelActive 3.0 is a medical device manufactured by Dentsply International, Inc.. It received FDA 510(k) clearance on 2016-01-14 under approval number K151039. 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 ATLANTIS Abutment for NobelActive 3.0?

ATLANTIS Abutment for NobelActive 3.0 is a medical device that received FDA 510(k) clearance on 2016-01-14. It is manufactured by Dentsply International, Inc.. The 510(k) number is K151039.

When was ATLANTIS Abutment for NobelActive 3.0 approved by the FDA?

ATLANTIS Abutment for NobelActive 3.0 received FDA 510(k) clearance on 2016-01-14, under approval number K151039.

What company makes ATLANTIS Abutment for NobelActive 3.0?

ATLANTIS Abutment for NobelActive 3.0 is manufactured by Dentsply International, Inc..

What is the FDA product code for ATLANTIS Abutment for NobelActive 3.0?

The FDA product code for ATLANTIS Abutment for NobelActive 3.0 is NHA.

Other Devices by Dentsply International, Inc.

K160207ATLANTIS ISUS Implant Suprastructures K160232Disposable Barrier Sleeves and Covers K151439ATLANTIS ISUS K152247ATLANTIS Crown

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.

↑