Cleared Traditional

K952592 - OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CROWN POST, 10 DEGREE & 20 DEGREE INCLINATIONS

K952592 is an FDA 510(k) clearance for OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CR..., manufactured by Opti-Max. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K952592 · Opti-Max · Dental device
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Sep 1995
Decision
108d
Days
Class 2
Risk

K952592 is an FDA 510(k) clearance for the OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CROWN POST, 10 DEGREE & 20 DEGREE INCLIN.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Opti-Max (Port Ludlow, US). The FDA issued a Cleared decision on September 21, 1995 after a review of 108 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.

FDA 510(k) Submission Details - K952592

510(k) Number K952592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1995
Decision Date September 21, 1995
Days to Decision 108 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 128d · This submission: 108d
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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K952592.
PHOENIX 3.25 MM HA COATED DENTAL IMPLANT
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INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM
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BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE)
K953775 · Nobelpharma USA, Inc. · Sep 1995
ABUTMENT
K953836 · Steri-Oss, Inc. · Sep 1995
OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW
K952634 · Opti-Max · Sep 1995
K952592 · OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CROWN POST, 10 DEGREE & 20 DEGREE INCLINATIONS
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