Cleared Traditional

K855032 - IMZ INTRAMOBILE CYLINDER IMPLANT

K855032 is an FDA 510(k) clearance for IMZ INTRAMOBILE CYLINDER IMPLANT, 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 77-day FDA review.

K855032 · Interpore Intl. · Dental device
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Mar 1986
Decision
77d
Days
Class 2
Risk

K855032 is an FDA 510(k) clearance for the IMZ INTRAMOBILE CYLINDER IMPLANT. 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 March 3, 1986 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 - K855032

510(k) Number K855032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1985
Decision Date March 03, 1986
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
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.

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.