Cleared Traditional

K963030 - LEIBINGER IMF SCREW

K963030 is an FDA 510(k) clearance for LEIBINGER IMF SCREW, manufactured by Howmedica Leibinger, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K963030 · Howmedica Leibinger, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
249d
Days
Class 2
Risk

K963030 is an FDA 510(k) clearance for the LEIBINGER IMF SCREW. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Howmedica Leibinger, Inc. (Dallas, US). The FDA issued a Cleared decision on April 11, 1997 after a review of 249 days - an extended review 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: 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 Howmedica Leibinger, Inc. devices

FDA 510(k) Submission Details - K963030

510(k) Number K963030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1996
Decision Date April 11, 1997
Days to Decision 249 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
122d slower than avg
Panel avg: 127d · This submission: 249d
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 980
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K963030.
ODONT HEX SYSTEM
K961631 · Odontit S.A. · May 1997
ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K971196 · Innova Corp. · May 1997
MINIMATIC VARIOUS IMPLANT SYSTEMS
K952905 · Minimatic, Inc. · Apr 1997
STERI-OSS TIODIZED SCREW
K964739 · Steri-Oss, Inc. · Mar 1997
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