Cleared Traditional

K923395 - VIDENT IMPAC IMPLANT ACCESSORIES

K923395 is the FDA 510(k) clearance for VIDENT IMPAC IMPLANT ACCESSORIES by Vident. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 865-day FDA review.

K923395 · Vident · Dental device
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Nov 1994
Decision
865d
Days
Class 2
Risk

K923395 is an FDA 510(k) clearance for the VIDENT IMPAC IMPLANT ACCESSORIES. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Vident (Baldwin Park, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 865 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 Vident devices

Submission Details

510(k) Number K923395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1992
Decision Date November 22, 1994
Days to Decision 865 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
738d slower than avg
Panel avg: 127d · This submission: 865d
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 674
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K923395.
BRANEMARK SYSTEM 17 ANGULATED ABUTMENT
K944962 · Nobelpharma USA, Inc. · Feb 1995
BRANEMARK SYSTEM SMILINE II
K944963 · Nobelpharma USA, Inc. · Feb 1995
RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)
K944068 · Lifecore Biomedical, Inc. · Feb 1995
IMPAC TORQUE WRENCH
K940998 · Vident · Nov 1994
VIDENT IMPAC INFINITE POSITION ABUTMENT
K941247 · Vident · Nov 1994
LORENZ SURGICAL THREADED DENTAL IMPLANT
K941619 · Biomet, Inc. · Sep 1994