Cleared Traditional

K984287 - PROVISIONAL DENTAL IMPLANT SYSTEM

K984287 is the FDA 510(k) clearance for PROVISIONAL DENTAL IMPLANT SYSTEM by Nobel Biocare Uas, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K984287 · Nobel Biocare Uas, Inc. · Dental device
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Mar 1999
Decision
90d
Days
Class 2
Risk

K984287 is an FDA 510(k) clearance for the PROVISIONAL DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobel Biocare Uas, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on March 1, 1999 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Nobel Biocare Uas, Inc. devices

Submission Details

510(k) Number K984287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1998
Decision Date March 01, 1999
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
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 672
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K984287.
PDQ AND PDQ-TI ABUTMENT
K990367 · Vident · Apr 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
OSSEOTITE DENTAL IMPLANTS
K983347 · Implant Innovations, Inc. · Jan 1999
3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT
K980083 · Implant Innovations, Inc. · Aug 1998