Cleared Traditional

MEMFIX (K955369) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K955369 · The Straumann Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
60d
Days
Class 2
Risk

K955369 is an FDA 510(k) clearance for the MEMFIX. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by The Straumann Co. (Cambridge, US). The FDA issued a Cleared decision on January 23, 1996 after a review of 60 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 The Straumann Co. devices

Submission Details

510(k) Number K955369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1995
Decision Date January 23, 1996
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 127d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 30
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K955369.
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K964261 · Synthes (Usa) · Apr 1997
LEW PROSTHETIC LOCKING DEVICE
K770131 · Howmedica Corp. · Jan 1977
LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM
K761228 · Howmedica Corp. · Dec 1976