Cleared Abbreviated

K072241 - PRIMACONNEX CAD/CAM ABUTMENT SYSTEM

K072241 is an FDA 510(k) clearance for PRIMACONNEX CAD/CAM ABUTMENT SYSTEM, manufactured by Lifecore Biomedical, Inc.. The device is a Class 2 Dental device with product code NHA cleared through the Abbreviated 510(k) pathway after a 88-day FDA review.

K072241 · Lifecore Biomedical, Inc. · Dental device
Download Printable Device Report (PDF)
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Nov 2007
Decision
88d
Days
Class 2
Risk

K072241 is an FDA 510(k) clearance for the PRIMACONNEX CAD/CAM ABUTMENT SYSTEM. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on November 9, 2007 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Lifecore Biomedical, Inc. devices

FDA 510(k) Submission Details - K072241

510(k) Number K072241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2007
Decision Date November 09, 2007
Days to Decision 88 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Standards-based clearance path.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 656
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K072241.
IMPLANTIUM PROSTHETICS
K070228 · Dentium Co., Ltd. · Nov 2007
ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS
K072483 · Atlantis Components, Inc. · Nov 2007
PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS
K073032 · Lifecore Biomedical, Inc. · Nov 2007
STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES
K071888 · Straumann USA · Oct 2007
P.004 ABUTMENTS
K072679 · Institut Straumann AG · Oct 2007
ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS
K071946 · Atlantis Components, Inc. · Oct 2007