Cleared Traditional

K960945 - IMZ MEMBRANE TACK SYSTEM

K960945 is an FDA 510(k) clearance for IMZ MEMBRANE TACK SYSTEM, manufactured by Interpore Intl.. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K960945 · Interpore Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
77d
Days
Class 2
Risk

K960945 is an FDA 510(k) clearance for the IMZ MEMBRANE TACK SYSTEM. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Interpore Intl. (Irvine, US). The FDA issued a Cleared decision on May 24, 1996 after a review of 77 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 Interpore Intl. devices

FDA 510(k) Submission Details - K960945

510(k) Number K960945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1996
Decision Date May 24, 1996
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
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 78
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K960945.
SMF TITANIUM (TI) ALLOY BONE SCREWS
K963546 · Synthes (Usa) · Jun 1997
SMF STAINLESS STEEL BONE SCREWS
K964261 · Synthes (Usa) · Apr 1997
OSTEOMED MSS
K961418 · Osteomed Corp. · Oct 1996
MEMFIX
K955369 · The Straumann Co. · Jan 1996
2.0 X 6MM SCREW
K955140 · Brasseler USA I, L.P. · Jan 1996
IMZ BONE TACK SYSTEM
K952167 · Interpore Intl. · Nov 1995