Cleared Traditional

BRINK PRE-MAXILLARY IMPLANT

K921580 · Implantech Associates, Inc. · General & Plastic Surgery
May 1992
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K921580 is an FDA 510(k) clearance for the BRINK PRE-MAXILLARY IMPLANT, a Prosthesis, Nose, Internal (Class II — Special Controls, product code FZE), submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on May 6, 1992, 34 days after receiving the submission on April 2, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3680.

Submission Details

510(k) Number K921580 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 1992
Decision Date May 06, 1992
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

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

Similar Devices — FZE Prosthesis, Nose, Internal

All 41
Medicon Epiplating System
K241253 · Cmf Medicon Surgical, Inc. · Dec 2024
Osseointegrated Fixtures
K161548 · Southern Implants (Pty), Ltd. · Dec 2016
HANSON MEDICAL FACIAL IMPLANTS
K090803 · Hanson Medical, Inc. · Jun 2010
NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
K090630 · Nobel Biocare AB · Jun 2009
MONARCH NASAL IMPLANT
K071018 · Hanson Medical, Inc. · May 2007
MONARCH NASAL IMPLANT
K041690 · Hanson Medical, Inc. · Feb 2005