Cleared Traditional

K952634 - OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW

K952634 is an FDA 510(k) clearance for OPTI-MAX EXTERNALLY THREADED EXTERNAL-H..., 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 102-day FDA review.

K952634 · Opti-Max · Dental device
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Sep 1995
Decision
102d
Days
Class 2
Risk

K952634 is an FDA 510(k) clearance for the OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPR.... 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 18, 1995 after a review of 102 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 Opti-Max devices

FDA 510(k) Submission Details - K952634

510(k) Number K952634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1995
Decision Date September 18, 1995
Days to Decision 102 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 127d · This submission: 102d
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 941
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K952634.
INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM
K943180 · Calcitek, Inc. · Sep 1995
BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE)
K953775 · Nobelpharma USA, Inc. · Sep 1995
ABUTMENT
K953836 · Steri-Oss, Inc. · Sep 1995
BRANEMARK SYSTEM DRILLS AND COUNTERSINKS
K952685 · Nobelpharma USA, Inc. · Sep 1995
BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEM
K952886 · Nobelpharma USA, Inc. · Sep 1995
DENTAL IMPLANT ENDOSSEOUS
K950066 · "O" Co., Inc. · Sep 1995