Cleared Traditional

K090630 - NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)

K090630 is an FDA 510(k) clearance for NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXI..., manufactured by Nobel Biocare AB. The device is a Class 2 General & Plastic Surgery device with product code FZE cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K090630 · Nobel Biocare AB · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
85d
Days
Class 2
Risk

K090630 is an FDA 510(k) clearance for the NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION). Classified as Prosthesis, Nose, Internal (product code FZE), Class II - Special Controls.

Submitted by Nobel Biocare AB (Yorba Linda,, US). The FDA issued a Cleared decision on June 2, 2009 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3680 - 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 Nobel Biocare AB devices

FDA 510(k) Submission Details - K090630

510(k) Number K090630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2009
Decision Date June 02, 2009
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZE Device Classification - Class 2, Special Controls

Product Code FZE Prosthesis, Nose, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3680
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FZE Prosthesis, Nose, Internal

All 24
Devices cleared under the same product code (FZE) and FDA review panel - the closest regulatory comparables to K090630.
Medicon Epiplating System
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MONARCH NASAL IMPLANT
K041690 · Hanson Medical, Inc. · Feb 2005
PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS
K992242 · Pillar Surgical, Inc. · Nov 1999
NASAL DORSAL SERIES
K983755 · Surgical Technology Laboratories, Inc. · Nov 1998
SEARE BIOMEDICAL NASAL IMPLANTS
K982753 · Seare Biomedical Corp. · Sep 1998