Cleared Traditional

K904391 - VIDENT IMPAC IMPLANT ACCESSORIES

K904391 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 440-day FDA review.

K904391 · Vident · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
440d
Days
Class 2
Risk

K904391 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 December 9, 1991 after a review of 440 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 K904391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1990
Decision Date December 09, 1991
Days to Decision 440 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
313d slower than avg
Panel avg: 127d · This submission: 440d
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 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K904391.
ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102
K905434 · Nobelpharma USA, Inc. · Aug 1992
STERI-OSS DRILLS AND TAPS
K915733 · Steri-Oss, Inc. · Jul 1992
BRANEMARK SYSTEM-3.0MM FIXTURE
K911960 · Nobelpharma USA, Inc. · Dec 1991
NOBELPHARMA CERAONE ABUTMENT SYSTEM
K910611 · Nobelpharma USA, Inc. · Aug 1991
BRANEMARK SYSTEM-5.0MM FIXTURE
K911961 · Nobelpharma USA, Inc. · Jul 1991
NOBELPHARMA DRILLING EQUIPMENT DEC 500
K905436 · Nobelpharma USA, Inc. · Mar 1991