Cleared Traditional

NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)

K090630 · Nobel Biocare AB · General & Plastic Surgery
Jun 2009
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K090630 is an FDA 510(k) clearance for the NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION), a Prosthesis, Nose, Internal (Class II — Special Controls, product code FZE), submitted by Nobel Biocare AB (Yorba Linda,, US). The FDA issued a Cleared decision on June 2, 2009, 85 days after receiving the submission on March 9, 2009. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3680.

Submission Details

510(k) Number K090630 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FZE — Prosthesis, Nose, Internal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3680

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