Cleared Traditional

K965135 - LIFECORE CONICAL ABUTMENT

K965135 is the FDA 510(k) clearance for LIFECORE CONICAL ABUTMENT by Lifecore Biomedical, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K965135 · Lifecore Biomedical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
64d
Days
Class 2
Risk

K965135 is an FDA 510(k) clearance for the LIFECORE CONICAL ABUTMENT. 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 February 25, 1997 after a review of 64 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 K965135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date February 25, 1997
Days to Decision 64 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
63d faster than avg
Panel avg: 127d · This submission: 64d
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 673
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K965135.
SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT RETAINED RESTORATIONS
K965077 · Implant Innovations, Inc. · Mar 1997
REPLACE TITANIUM IMPLANT SYSTEM
K964220 · Steri-Oss, Inc. · Mar 1997
DENTSPLY PRECISION TORQUE SYSTEM
K964046 · Dentsply Intl. · Mar 1997
STERI-OSS GOLD ATTACHMENT SYSTEM
K963945 · Steri-Oss, Inc. · Feb 1997
ROUND DENTAL BUR
K964944 · Steri-Oss, Inc. · Feb 1997
BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)
K964330 · BioHorizons Implant Systems, Inc. · Jan 1997