Cleared Traditional

K994205 - MODIFICATION OF REGULAR DIAMETER SINGLE...

K994205 is the FDA 510(k) clearance for MODIFICATION OF REGULAR DIAMETER SINGLE... by Lifecore Biomedical, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K994205 · Lifecore Biomedical, Inc. · Dental device
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Feb 2000
Decision
90d
Days
Class 2
Risk

K994205 is an FDA 510(k) clearance for the MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS 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 February 29, 2000 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Lifecore Biomedical, Inc. devices

Submission Details

510(k) Number K994205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1999
Decision Date February 29, 2000
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 K994205.
SYNOCTA ANGLED ABUTMENTS
K994119 · Straumann USA · Mar 2000
LIFECORE SINGLE TOOTH ABUTMENT SYSTEM
K993894 · Lifecore Biomedical, Inc. · Mar 2000
DENTAL IMPLANT
K992937 · Nobel Biocare Uas, Inc. · Feb 2000
NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT)
K993595 · Nobel Biocare Uas, Inc. · Jan 2000
AMORPHOUS DIAMOND COATED SCREW
K992538 · Nobel Biocare Uas, Inc. · Nov 1999
ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING
K992334 · Implant Innovations, Inc. · Oct 1999