Cleared Traditional

OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS (K905223) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K905223 · Universal Implant Systems, Inc. · Dental device
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Aug 1991
Decision
269d
Days
Class 2
Risk

K905223 is an FDA 510(k) clearance for the OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Universal Implant Systems, Inc. (Washington, US). The FDA issued a Cleared decision on August 16, 1991 after a review of 269 days - an extended review 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: 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 Universal Implant Systems, Inc. devices

Submission Details

510(k) Number K905223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date August 16, 1991
Days to Decision 269 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 127d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.