Cleared Traditional

K926102 - PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN

K926102 is an FDA 510(k) clearance for PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-..., manufactured by Phoenix Dental, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 566-day FDA review.

K926102 · Phoenix Dental, Inc. · Dental device
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Jun 1994
Decision
566d
Days
Class 2
Risk

K926102 is an FDA 510(k) clearance for the PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Phoenix Dental, Inc. (San Diego, US). The FDA issued a Cleared decision on June 22, 1994 after a review of 566 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K926102

510(k) Number K926102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1992
Decision Date June 22, 1994
Days to Decision 566 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
438d slower than avg
Panel avg: 128d · This submission: 566d
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 1532
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K926102.
SARGON CYLINDRO-BLADE IMPLANT
K930071 · Sargon Ent., Inc. · Jul 1994
PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO
K926101 · Phoenix Dental, Inc. · Jun 1994
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
K924589 · Implant Support Systems, Inc. · Jun 1994
ZEST IMPLANT ANCHOR ADVANCED GENERATION (DENTAL)
K934668 · Zest Anchors, Inc. · Jun 1994
IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM
K932123 · Implant Innovations International, Inc. · May 1994
HAND INSTRUMENT CALCULUS REMOVAL
K925312 · Implant Support Systems, Inc. · May 1994
K926102 · PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN
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