Cleared Traditional

K955492 - INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT

K955492 is an FDA 510(k) clearance for INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT, 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 60-day FDA review.

K955492 · Interpore Intl. · Dental device
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Jan 1996
Decision
60d
Days
Class 2
Risk

K955492 is an FDA 510(k) clearance for the INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT. 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 January 30, 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 872.3640 - 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: 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 - K955492

510(k) Number K955492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1995
Decision Date January 30, 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.

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 K955492.
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
K954512 · Lifecore Biomedical, Inc. · Feb 1996
3I TITANIUM PLASMA SPRAYED STANDARD THREADED & SELF-TAPPING IMPLANTS
K955427 · Implant Innovations, Inc. · Feb 1996
3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS
K955428 · Implant Innovations, Inc. · Feb 1996
ABUTMENT RETRIEVAL KIT
K955697 · Nobelpharma USA, Inc. · Jan 1996
BALL ATTACHMENT SYSTEM
K955372 · Nobelpharma USA, Inc. · Jan 1996
RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM
K954819 · Lifecore Biomedical, Inc. · Jan 1996