Cleared Traditional

K905223 - OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS

K905223 is an FDA 510(k) clearance for OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS, manufactured by Universal Implant Systems, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K905223 · Universal Implant Systems, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K905223

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.

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 1161
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K905223.
VIDENT IMPAC IMPLANT ACCESSORIES
K904391 · Vident · Dec 1991
TCAL ABUTMENT
K913782 · Core-Vent Corp. · Oct 1991
TSIR ANGLED ABUTMENTS
K910585 · Core-Vent Corp. · Oct 1991
NOBELPHARMA CERAONE ABUTMENT SYSTEM
K910611 · Nobelpharma USA, Inc. · Aug 1991
BRANEMARK SYSTEM-5.0MM FIXTURE
K911961 · Nobelpharma USA, Inc. · Jul 1991
HH-1119 HEALING HEAD
K903515 · Minimatic Implant Technology · Jul 1991