Cleared Traditional

K032774 - RENOVA INTERNAL HEX IMPLANT SYSTEM

K032774 is an FDA 510(k) clearance for RENOVA INTERNAL HEX IMPLANT SYSTEM, manufactured by Lifecore Biomedical, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K032774 · Lifecore Biomedical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
79d
Days
Class 2
Risk

K032774 is an FDA 510(k) clearance for the RENOVA INTERNAL HEX 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 November 26, 2003 after a review of 79 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

FDA 510(k) Submission Details - K032774

510(k) Number K032774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2003
Decision Date November 26, 2003
Days to Decision 79 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
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1186
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K032774.
OSTEOMED ORTHODONTIC SCREW SYSTEM
K031936 · Osteomed LP · Jan 2004
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K033922 · Institut Straumann AG · Jan 2004
IMMEDIATE STABILIZING IMPLANT (ISI)
K033392 · "O" Co., Inc. · Dec 2003
3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615
K033430 · Implant Innovations, Inc. · Nov 2003
THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT
K032351 · BioHorizons Implant Systems, Inc. · Oct 2003
XIVE TG ABUTMENTS
K032302 · Friadent GmbH · Oct 2003