Cleared Traditional

K952167 - IMZ BONE TACK SYSTEM

K952167 is an FDA 510(k) clearance for IMZ BONE 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 197-day FDA review.

K952167 · Interpore Intl. · Dental device
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Nov 1995
Decision
197d
Days
Class 2
Risk

K952167 is an FDA 510(k) clearance for the IMZ BONE 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 November 21, 1995 after a review of 197 days - an extended review 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: 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 Interpore Intl. devices

FDA 510(k) Submission Details - K952167

510(k) Number K952167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1995
Decision Date November 21, 1995
Days to Decision 197 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 127d · This submission: 197d
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 52
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K952167.
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 SCREWS
K910427 · W.L. Gore & Associates, Inc. · Sep 1991
OSTEOMED SBF SYSTEM (SBF)
K911936 · Osteomed Corp. · Aug 1991
LEW PROSTHETIC LOCKING DEVICE
K770131 · Howmedica Corp. · Jan 1977