Cleared Traditional

K874400 - NON-ROTATING GOLD CYLINDER AND SCREW

K874400 is an FDA 510(k) clearance for NON-ROTATING GOLD CYLINDER AND SCREW, manufactured by Implant Innovations International, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K874400 · Implant Innovations International, Inc. · Dental device
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Mar 1988
Decision
126d
Days
Class 2
Risk

K874400 is an FDA 510(k) clearance for the NON-ROTATING GOLD CYLINDER AND SCREW. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Innovations International, Inc. (West Palm Beach, US). The FDA issued a Cleared decision on March 2, 1988 after a review of 126 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 Implant Innovations International, Inc. devices

FDA 510(k) Submission Details - K874400

510(k) Number K874400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date March 02, 1988
Days to Decision 126 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 127d · This submission: 126d
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 868
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K874400.
IMZ O-RING ATTACHMENT
K883211 · Interpore Intl. · Nov 1988
INNOVATIVE IMPLANTS AND COVER SCREWS
K874590 · Implant Innovations International, Inc. · May 1988
THE MICRO-VENT/HA
K873255 · Core-Vent Corp. · Mar 1988
VENT CORP PIB IMPLANT
K873818 · Core-Vent Corp. · Feb 1988
TEMPORARY BRIDGE HEAD
K871953 · Implant Innovations International, Inc. · Jul 1987
ABUTMENT HEAD POST
K871954 · Implant Innovations International, Inc. · Jul 1987