Cleared Traditional

K990367 - PDQ AND PDQ-TI ABUTMENT

K990367 is the FDA 510(k) clearance for PDQ AND PDQ-TI ABUTMENT by Vident. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K990367 · Vident · Dental device
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Apr 1999
Decision
75d
Days
Class 2
Risk

K990367 is an FDA 510(k) clearance for the PDQ AND PDQ-TI ABUTMENT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Vident (Brea, US). The FDA issued a Cleared decision on April 21, 1999 after a review of 75 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vident devices

Submission Details

510(k) Number K990367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1999
Decision Date April 21, 1999
Days to Decision 75 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
52d faster than avg
Panel avg: 127d · This submission: 75d
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 K990367.
3I CERAMIC ABUTMENT SYSTEM
K991947 · Implant Innovations, Inc. · Sep 1999
SYNOCTA PROSTHETICS
K990342 · Straumann USA · Jul 1999
ITI DENTAL IMPLANT SYSTEM
K984104 · Straumann USA · May 1999
O-RING ABUTMENT
K990277 · BioHorizons Implant Systems, Inc. · Apr 1999
ITI DENTAL IMPLANT SYSTEM
K983742 · Institut Straumann AG · Mar 1999
WIDE BODY ABUTMENTS
K984198 · Vident · Feb 1999