Cleared Traditional

K921246 - IMZ SURGICAL INSTRUMENT TRAY

K921246 is an FDA 510(k) clearance for IMZ SURGICAL INSTRUMENT TRAY, manufactured by Interpore Intl.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K921246 · Interpore Intl. · Dental device
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Jun 1992
Decision
98d
Days
Class 2
Risk

K921246 is an FDA 510(k) clearance for the IMZ SURGICAL INSTRUMENT TRAY. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Interpore Intl. (Irvine, US). The FDA issued a Cleared decision on June 22, 1992 after a review of 98 days - within the typical 510(k) review window.

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 Interpore Intl. devices

FDA 510(k) Submission Details - K921246

510(k) Number K921246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1992
Decision Date June 22, 1992
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
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 699
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K921246.
HEXLOCK SCREW
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K915733 · Steri-Oss, Inc. · Jul 1992
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K911776 · Minimatic Implant Technology · Jan 1992
BRANEMARK SYSTEM-3.0MM FIXTURE
K911960 · Nobelpharma USA, Inc. · Dec 1991
HEXLOCK
K912262 · Imtec Corp. · Dec 1991