Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)

FDA 510(k) K150669 · Neoss, Ltd.

Substantially Equivalent

510(k) numberK150669

Submission

Device name
Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)
Applicant
Neoss, Ltd.
Harrogate, GB
Received
March 16, 2015
Decision date
October 8, 2015
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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K260564DESS Dental Smart SolutionsNHA · Traditional Terrats Medical SL06/09/2026SE
K252904SIC Abutments including CAD/CAM SolutionsNHA · Traditional Sic Invent AG06/03/2026SE
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More from Hiossen, Inc.

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K211396Neoss Individual ProstheticsNHA · Traditional 05/17/2022SE
K201561Membrane Screws and Membrane TacksDZL · Traditional 10/05/2020SE
K143327Neoss Ti Reinforced MembraneNPK · Traditional 04/13/2015SE
K113376Neoss Proactive Tapered ImplantDZE · Traditional 09/05/2012SE
K090452Neoss Implant System 03.25DZE · Traditional 05/22/2009SE
K081851Neoss Access AbutmentsNHA · Traditional 03/02/2009SE
K083561Neoss Proactive ImplantDZE · Special 02/11/2009SE
K071838Neoss Various Titanium AbutmentsNHA · Traditional 10/19/2007SE
K043195Neo Implant SystemDZE · Traditional 03/07/2005SE

Questions and answers

When was Neoss TiBase, Neoss CoCr Abutments (Mono and Multi) cleared by the FDA?

Neoss TiBase, Neoss CoCr Abutments (Mono and Multi) (K150669) received a 510(k) decision of Substantially Equivalent on October 8, 2015, 206 days after the submission was received.

What is the product code of K150669?

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