Primaconnex Cad/Cam Abutment System

FDA 510(k) K072241 · Lifecore Biomedical, Inc.

Substantially Equivalent

510(k) numberK072241

Submission

Device name
Primaconnex Cad/Cam Abutment System
Applicant
Lifecore Biomedical, Inc.
Chaska, MN, US
Received
August 13, 2007
Decision date
November 9, 2007
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 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.

510(k)DeviceDecision
K073032Primaconnex SD Esthetic Contour Zi AbutmentsNHA · Special 11/16/2007SE
K072768Restore, STAGE-1, Renova Primasolo and Primaconnex Dental ImplantsDZE · Special 10/23/2007SE
K072572Primaconnex RD and WD Esthetic Contour Zi AbutmentsNHA · Special 10/05/2007SE
K062876Primaconnex Ceramic AbutmentsNHA · Traditional 11/01/2006SE
K060530SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD Ceramic Coping for Quick…ELL · Traditional 05/22/2006SE
K053643Stage- 1 Temporary/Healing Cap, Model 42021-42026NHA · Special 01/23/2006SE
K051614Primaconnex Internal Connection Implant System, Primaconnex Internal Connection…DZE · Abbreviated 09/09/2005SE
K050506Primasolo One-Piece Implants & Healing CapsDZE · Abbreviated 04/15/2005SE
K041324Calmatrix Calcium Sulfate Bone Graft BinderLYC · Traditional 07/19/2004SE
K032774Renova Internal Hex Implant SystemDZE · Traditional 11/26/2003SE

Questions and answers

When was Primaconnex Cad/Cam Abutment System cleared by the FDA?

Primaconnex Cad/Cam Abutment System (K072241) received a 510(k) decision of Substantially Equivalent on November 9, 2007, 88 days after the submission was received.

What is the product code of K072241?

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