FZE · Class II · 21 CFR 878.3680

FDA Product Code FZE: Prosthesis, Nose, Internal

Leading manufacturers include Implantech Associates, Inc., Nobel Biocare AB and Cmf Medicon Surgical, Inc..

42
Total
42
Cleared
83d
Avg days
1978
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 223d recently vs 80d historically

FDA 510(k) Cleared Prosthesis, Nose, Internal Devices (Product Code FZE)

42 devices
1–24 of 42
Cleared Dec 12, 2024
Medicon Epiplating System
K241253
Cmf Medicon Surgical, Inc.
General & Plastic Surgery · 223d
Cleared Jun 02, 2009
NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
K090630
Nobel Biocare AB
General & Plastic Surgery · 85d
Cleared Oct 03, 1996
IMPLANTECH JEJ PERI-PYRIFORM IMPLANT
K962824
Implantech Associates, Inc.
General & Plastic Surgery · 76d
Cleared Jan 13, 1995
BA-CPAS
K945154
Nobelpharma USA, Inc.
General & Plastic Surgery · 84d
Cleared Aug 17, 1994
IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II
K941960
Implantech Associates, Inc.
General & Plastic Surgery · 117d
Cleared Jul 18, 1994
IMPLANTECH DORSAL NASAL IMPLANT
K942876
Implantech Associates, Inc.
General & Plastic Surgery · 31d
Cleared Aug 10, 1993
NASAL DORSUM
K925743
Smith & Nephew Richards, Inc.
General & Plastic Surgery · 270d
Cleared May 12, 1993
RIZZO NASAL IMPLANT
K925426
Implantech Associates, Inc.
General & Plastic Surgery · 197d
Cleared May 06, 1992
BRINK PRE-MAXILLARY IMPLANT
K921580
Implantech Associates, Inc.
General & Plastic Surgery · 34d
Cleared Dec 18, 1990
FLOWERS NASAL IMPLANT
K904656
Implantech Associates, Inc.
General & Plastic Surgery · 64d
Cleared Dec 18, 1990
FLOWERS DORSAL COLUMELLA IMPLANT
K904657
Implantech Associates, Inc.
General & Plastic Surgery · 64d
Cleared Feb 18, 1988
SILASTIC NASAL IMPLANT S-TYPE
K880405
Dow Corning Wright
General & Plastic Surgery · 20d
Cleared Sep 27, 1978
PLASTI-PORE SEPTAL BUTTON
K781574
Richard'S Medical Equip., Inc.
General & Plastic Surgery · 9d

About Product Code FZE - Regulatory Context

510(k) Submission Activity

42 total 510(k) submissions under product code FZE since 1978, with 42 receiving FDA clearance (average review time: 83 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - FZE Product Code

Recent submissions under FZE have taken an average of 223 days to reach a decision - up from 80 days historically. Manufacturers should account for longer review timelines in current project planning.

FZE devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →