Cleared Traditional

K904611 - INTERPORE CYLINDRICAL HEX IMPLANT

K904611 is an FDA 510(k) clearance for INTERPORE CYLINDRICAL HEX 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 117-day FDA review.

K904611 · Interpore Intl. · Dental device
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Feb 1991
Decision
117d
Days
Class 2
Risk

K904611 is an FDA 510(k) clearance for the INTERPORE CYLINDRICAL HEX 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 February 5, 1991 after a review of 117 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 - K904611

510(k) Number K904611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1990
Decision Date February 05, 1991
Days to Decision 117 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 127d · This submission: 117d
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 K904611.
BC 1213 HEALING SCREW
K904709 · Minimatic Implant Technology · Mar 1991
BC-1201 CAST ABUTMENT
K904703 · Minimatic Implant Technology · Mar 1991
NOBELPHARMA DRILLING EQUIPMENT DEC 500
K905436 · Nobelpharma USA, Inc. · Mar 1991
DEVICE PART NUMBER DPI-1106 IMPLANT
K902928 · Minimatic Implant Technology · Jan 1991
BC 1220 ANALOG - IMPLANT BODY
K904711 · Minimatic Implant Technology · Jan 1991
CGA-112 COPING GOLD ALLOY
K903113 · Minimatic Implant Technology · Dec 1990