Cleared Abbreviated

K051614 - PRIMACONNEX INTERNAL CONNECTION IMPLANT...

K051614 is the FDA 510(k) clearance for PRIMACONNEX INTERNAL CONNECTION IMPLANT... by Lifecore Biomedical, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Abbreviated 510(k) pathway after a 84-day FDA review.

K051614 · Lifecore Biomedical, Inc. · Dental device
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Sep 2005
Decision
84d
Days
Class 2
Risk

K051614 is an FDA 510(k) clearance for the PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTI.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on September 9, 2005 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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

Submission Details

510(k) Number K051614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2005
Decision Date September 09, 2005
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 604
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K051614.
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K051461 · Implant Innovations, Inc. · Sep 2005
NOBELSPEEDY IMPLANTS
K050406 · Nobel Biocare AB · Jun 2005
PREVAIL DENTAL IMPLANTS
K051189 · Implant Innovations, Inc. · Jun 2005
TIUNITE IMPLANTS
K050705 · Nobel Biocare AB · May 2005