Cleared Traditional

K926311 - PHOENIX 4.0 MM ANGLED DENTAL ATTACHMENTS

K926311 is an FDA 510(k) clearance for PHOENIX 4.0 MM ANGLED DENTAL ATTACHMENTS, 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 1010-day FDA review.

K926311 · Vancouver Implant Center · Dental device
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Sep 1995
Decision
1010d
Days
Class 2
Risk

K926311 is an FDA 510(k) clearance for the PHOENIX 4.0 MM ANGLED DENTAL ATTACHMENTS. 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 September 21, 1995 after a review of 1010 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 - K926311

510(k) Number K926311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1992
Decision Date September 21, 1995
Days to Decision 1010 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
883d slower than avg
Panel avg: 127d · This submission: 1010d
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 1188
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K926311.
BRANEMARK RADIOGRAPHIC DEPTH GUAGE
K953435 · Nobelpharma USA, Inc. · Oct 1995
3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM)
K950204 · Implant Innovations, Inc. · Sep 1995
BRANEMARK RESTORATIVE INSTRUMENT & COMPONENT TRAY
K953774 · Nobelpharma USA, Inc. · Sep 1995
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