Cleared Traditional

K974392 - LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM

K974392 is an FDA 510(k) clearance for LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM, manufactured by Biovision GmbH. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K974392 · Biovision GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
70d
Days
Class 2
Risk

K974392 is an FDA 510(k) clearance for the LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Biovision GmbH (Carlsbad, US). The FDA issued a Cleared decision on January 30, 1998 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - 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 Biovision GmbH devices

FDA 510(k) Submission Details - K974392

510(k) Number K974392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1997
Decision Date January 30, 1998
Days to Decision 70 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
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZL Device Classification - Class 2, Special Controls

Product Code DZL Screw, Fixation, Intraosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4880
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 - DZL Screw, Fixation, Intraosseous

All 62
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K974392.
SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR
K981362 · Synthes (Usa) · Jun 1998
SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS
K980199 · Synthes (Usa) · Apr 1998
DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM
K974817 · Doctor'S Research Group, Inc. · Mar 1998
3I BIORESORBABLE FIXATION TACK
K972480 · Implant Innovations, Inc. · Dec 1997
IMTEC BONE TAC
K973180 · Imtec Corp. · Nov 1997
BONE GRAFT SCREW SYSTEM
K973056 · Bicon, Inc. · Nov 1997