Cleared Abbreviated

K050506 - PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS

K050506 is an FDA 510(k) clearance for PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS, manufactured by Lifecore Biomedical, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 46-day FDA review.

K050506 · Lifecore Biomedical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
46d
Days
Class 2
Risk

K050506 is an FDA 510(k) clearance for the PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS. 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 April 15, 2005 after a review of 46 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

FDA 510(k) Submission Details - K050506

510(k) Number K050506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2005
Decision Date April 15, 2005
Days to Decision 46 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
81d faster than avg
Panel avg: 127d · This submission: 46d
Pathway characteristics
Standards-based clearance path.

DZE Device Classification - Class 2, Special Controls

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 1207
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K050506.
THE GUIDED SURGERY CONCEPT
K050393 · Nobel Biocare AB · May 2005
4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT
K050712 · Bicon, Inc. · Apr 2005
GROOVY IMPLANTS
K050258 · Nobel Biocare AB · Apr 2005
BICON ORTHODONTIC IMPLANT SYSTEM
K050408 · Bicon, Inc. · Apr 2005
NEO IMPLANT SYSTEM
K043195 · Neoss, Ltd. · Mar 2005
LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)
K050257 · Mondeal Medical Systems GmbH · Feb 2005