Cleared Traditional

K905434 - ANGULATED ABUTMENT

K905434 is the FDA 510(k) clearance for ANGULATED ABUTMENT by Nobelpharma USA, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 632-day FDA review.

K905434 · Nobelpharma USA, Inc. · Dental device
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Aug 1992
Decision
632d
Days
Class 2
Risk

K905434 is an FDA 510(k) clearance for the ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobelpharma USA, Inc. (Chicago, US). The FDA issued a Cleared decision on August 27, 1992 after a review of 632 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Nobelpharma USA, Inc. devices

Submission Details

510(k) Number K905434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1990
Decision Date August 27, 1992
Days to Decision 632 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
505d slower than avg
Panel avg: 127d · This submission: 632d
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 674
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K905434.
BRANEMARK SYSTEM ESTHETICONE ABUTMENT COMPLETE
K925777 · Nobelpharma USA, Inc. · Apr 1993
BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES
K925778 · Nobelpharma USA, Inc. · Apr 1993
BRANEMARK SYSTEM HEALING CAPS
K925780 · Nobelpharma USA, Inc. · Apr 1993
STERI-OSS DRILLS AND TAPS
K915733 · Steri-Oss, Inc. · Jul 1992
DPI-1106 IMPLANT, MODIFICATION
K911776 · Minimatic Implant Technology · Jan 1992
BRANEMARK SYSTEM-3.0MM FIXTURE
K911960 · Nobelpharma USA, Inc. · Dec 1991