Cleared Traditional

K965077 - SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ...

K965077 is the FDA 510(k) clearance for SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ... by Implant Innovations, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K965077 · Implant Innovations, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
90d
Days
Class 2
Risk

K965077 is an FDA 510(k) clearance for the SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT RETA.... 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 March 17, 1997 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 Implant Innovations, Inc. devices

Submission Details

510(k) Number K965077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1996
Decision Date March 17, 1997
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 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K965077.
3I INNOVATIVE IMPLANTS AND COVER SCREWS
K972444 · Implant Innovations, Inc. · Aug 1997
ENDOSSEOUS DENTAL IMPLANT
K971578 · Straumann USA · Jun 1997
STERI-OSS TIODIZED SCREW
K964739 · Steri-Oss, Inc. · Mar 1997
REPLACE TITANIUM IMPLANT SYSTEM
K964220 · Steri-Oss, Inc. · Mar 1997
DENTSPLY PRECISION TORQUE SYSTEM
K964046 · Dentsply Intl. · Mar 1997
STERI-OSS GOLD ATTACHMENT SYSTEM
K963945 · Steri-Oss, Inc. · Feb 1997