Preformance Posts

FDA 510(k) K053170 · Implant Innovations, Inc.

Substantially Equivalent

510(k) numberK053170

Submission

Device name
Preformance Posts
Applicant
Implant Innovations, Inc.
Palm Beach Gardens, FL, US
Received
November 14, 2005
Decision date
February 1, 2006
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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K062636Osseotite, Osseotite Ny, Certain, Certain NT, Prevail, Certain Prevail, XP…DZE · Traditional 06/01/2007SE
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K061629Certain Prevail Dental ImplantDZE · Special 02/23/2007SE
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K061969Preformance Posts and Temporary CylindersNHA · Special 07/21/2006SE
K061177Provide Temporary CylinderNHA · Special 05/16/2006SE
K060291Preformance Temporary CylinderNHA · Special 02/27/2006SE
K052648Modification to 3I Patient-Specific Dental Abutments and Overdenture BarsNHA · Special 10/20/2005SE

Questions and answers

When was Preformance Posts cleared by the FDA?

Preformance Posts (K053170) received a 510(k) decision of Substantially Equivalent on February 1, 2006, 79 days after the submission was received.

What is the product code of K053170?

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