Cleared Traditional

K962647 - ANGLED ABUTMENT

K962647 is the FDA 510(k) clearance for ANGLED ABUTMENT by Straumann USA. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K962647 · Straumann USA · Dental device
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Optimized for regulatory review, auditing and printing
Oct 1996
Decision
91d
Days
Class 2
Risk

K962647 is an FDA 510(k) clearance for the ANGLED ABUTMENT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Straumann USA (Cambridge, US). The FDA issued a Cleared decision on October 7, 1996 after a review of 91 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 Straumann USA devices

Submission Details

510(k) Number K962647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1996
Decision Date October 07, 1996
Days to Decision 91 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
36d faster than avg
Panel avg: 127d · This submission: 91d
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 K962647.
3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC.
K962014 · Implant Innovations, Inc. · Oct 1996
REPLACE TPS COATED IMPLANTS
K962844 · Steri-Oss, Inc. · Oct 1996
REPLACE HA COATED IMPLANTS
K962845 · Steri-Oss, Inc. · Oct 1996
TIL313 ABUTMENT AND RETAINING SCREW SYSTEMS
K962465 · Implant Innovations, Inc. · Sep 1996
NOBLEPHARMA WIDE ACCESSORIES
K962403 · Nobelpharma USA, Inc. · Sep 1996
OSTEO COMPACTION KIT
K962449 · Steri-Oss, Inc. · Sep 1996