Cleared Traditional

K931647 - PHOENIX 4.0 MM HA COATED DENTAL IMPLANT

K931647 is an FDA 510(k) clearance for PHOENIX 4.0 MM HA COATED DENTAL IMPLANT, manufactured by Vancouver Implant Center. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 1065-day FDA review.

K931647 · Vancouver Implant Center · Dental device
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Mar 1996
Decision
1065d
Days
Class 2
Risk

K931647 is an FDA 510(k) clearance for the PHOENIX 4.0 MM HA COATED DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Vancouver Implant Center (V7k 2x4, CA). The FDA issued a Cleared decision on March 5, 1996 after a review of 1065 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.

View all Vancouver Implant Center devices

FDA 510(k) Submission Details - K931647

510(k) Number K931647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1993
Decision Date March 05, 1996
Days to Decision 1065 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
938d slower than avg
Panel avg: 127d · This submission: 1065d
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 1187
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K931647.
KIS MT5
K960112 · The Implant Center of the Palm Beaches · Mar 1996
5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS
K955619 · Calcitek, Inc. · Mar 1996
INTERPORE THREADED IMPLANT
K960371 · Interpore Intl. · Mar 1996
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
K954512 · Lifecore Biomedical, Inc. · Feb 1996
3I TITANIUM PLASMA SPRAYED STANDARD THREADED & SELF-TAPPING IMPLANTS
K955427 · Implant Innovations, Inc. · Feb 1996
INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM
K943604 · Calcitek, Inc. · Feb 1996