Cleared Traditional

K980083 - 3I ORTHODONTIC ABUTMENT

K980083 is the FDA 510(k) clearance for 3I ORTHODONTIC ABUTMENT by Implant Innovations, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K980083 · Implant Innovations, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
220d
Days
Class 2
Risk

K980083 is an FDA 510(k) clearance for the 3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Innovations, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on August 17, 1998 after a review of 220 days - an extended review 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: 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 Implant Innovations, Inc. devices

Submission Details

510(k) Number K980083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1998
Decision Date August 17, 1998
Days to Decision 220 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
93d slower than avg
Panel avg: 127d · This submission: 220d
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 K980083.
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
OSSEOTITE DENTAL IMPLANT SYSTEM
K980549 · Implant Innovations, Inc. · Apr 1998
REPLACE CYLINDRICAL IMPLANTS
K980439 · Steri-Oss, Inc. · Mar 1998
IMPLANT SITE DILATORS
K980374 · BioHorizons Implant Systems, Inc. · Mar 1998