Cleared Traditional

OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL (K944943) - FDA 510(k) Clearance

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

K944943 · Opti-Max · Dental device
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Mar 1995
Decision
157d
Days
Class 2
Risk

K944943 is an FDA 510(k) clearance for the OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL. 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 March 13, 1995 after a review of 157 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 Opti-Max devices

Submission Details

510(k) Number K944943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1994
Decision Date March 13, 1995
Days to Decision 157 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
30d slower than avg
Panel avg: 127d · This submission: 157d
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.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 303
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