Cleared Traditional

K003226 - THE LIFECORE STAGE-1 SINGLE STAGE RBM D...

K003226 is the FDA 510(k) clearance for THE LIFECORE STAGE-1 SINGLE STAGE RBM D... by Lifecore Biomedical, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K003226 · Lifecore Biomedical, Inc. · Dental device
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Jan 2001
Decision
88d
Days
Class 2
Risk

K003226 is an FDA 510(k) clearance for the THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM. 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 January 12, 2001 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lifecore Biomedical, Inc. devices

Submission Details

510(k) Number K003226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2000
Decision Date January 12, 2001
Days to Decision 88 days
Submission Type Traditional
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
Predicate-based equivalence. No clinical trials required.

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 674
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K003226.
ITI DENTAL IMPLANT SYSTEM
K010291 · Straumann USA · May 2001
THE MAESTRO SYSTEM
K010458 · BioHorizons Implant Systems, Inc. · May 2001
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K003271 · Institut Straumann AG · Mar 2001
REPLACE TPS COATED IMPLANTS
K002475 · Nobel Biocare Uas, Inc. · Nov 2000
ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT
K002374 · Straumann USA · Nov 2000
INPLANT ORTHODONTIC ANCHOR SYSTEM
K000643 · Nobel Biocare Uas, Inc. · Sep 2000