Cleared Traditional

K990458 - STRAUMANN EXTRAORAL IMPLANT SYSTEM

K990458 is the FDA 510(k) clearance for STRAUMANN EXTRAORAL IMPLANT SYSTEM by Straumann USA. It is a Class 1 General & Plastic Surgery device (product code KCZ) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K990458 · Straumann USA · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
63d
Days
Class 1
Risk

K990458 is an FDA 510(k) clearance for the STRAUMANN EXTRAORAL IMPLANT SYSTEM. Classified as Prosthesis, Breast, External, Used With Adhesive (product code KCZ), Class I - General Controls.

Submitted by Straumann USA (Waltham, US). The FDA issued a Cleared decision on April 16, 1999 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Straumann USA devices

Submission Details

510(k) Number K990458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1999
Decision Date April 16, 1999
Days to Decision 63 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCZ Prosthesis, Breast, External, Used With Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.3800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KCZ Prosthesis, Breast, External, Used With Adhesive

Devices cleared under the same product code (KCZ) and FDA review panel - the closest regulatory comparables to K990458.
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