ATLANTIS ISUS Implant Suprastructures

Q: What is the product code of K160207?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.

FDA 510(k) K160207 · Dentsply International, Inc.

Substantially Equivalent

510(k) numberK160207

Submission

Device name: ATLANTIS ISUS Implant Suprastructures
Applicant: Dentsply International, Inc.
York, PA, US
Received: January 28, 2016
Decision date: September 21, 2016
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NHA – Abutment, Implant, Dental, Endosseous
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.3630
Specialty: Dental
Implant: Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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More from Hiossen, Inc.

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K152247	ATLANTIS CrownEIH · Traditional	01/29/2016SE
K151039	ATLANTIS Abutment for NobelActive 3.0NHA · Traditional	01/14/2016SE
K151619	Prime&Bond Elect Universal Dental AdhesiveKLE · Traditional	10/30/2015SE
K150535	Cavitron Touch Ultrasonic Scaling SystemELC · Traditional	06/16/2015SE
K142178	Proroot Mta White, Proroot Mta GrayKIF · Traditional	02/26/2015SE
K131907	Raypex 6LQY · Traditional	01/31/2014SE
K131644	Ankylos Syncone Abutment 5(DEGREE)NHA · Traditional	01/22/2014SE
K132145	Mtm(R) Clear AlignerNXC · Traditional	10/11/2013SE

Questions and answers

When was ATLANTIS ISUS Implant Suprastructures cleared by the FDA?

ATLANTIS ISUS Implant Suprastructures (K160207) received a 510(k) decision of Substantially Equivalent on September 21, 2016, 237 days after the submission was received.

What is the product code of K160207?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.