Product Code: FZE FDA class 2 21 CFR 878.3680

Prosthesis, Nose, Internal

General, Plastic Surgery

An internal nasal prosthesis is a surgically implanted device used to reconstruct or augment the nose following trauma, congenital defects, or surgical resection, providing structural support or cosmetic restoration. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FZE, regulated under 21 CFR 878.3680, within the General, Plastic Surgery medical specialty. This device is designated as an implant.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FZE
Device Class: FDA class 2
Regulation Number: 878.3680
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 42 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241253	Medicon Epiplating System	Dec 12, 2024	Substantially Equivalent	Cmf Medicon Surgical, Inc.
K161548	Osseointegrated Fixtures	Dec 01, 2016	Substantially Equivalent	Southern Implants (Pty), Ltd.
K090803	HANSON MEDICAL FACIAL IMPLANTS	Jun 30, 2010	Substantially Equivalent	Hanson Medical, Inc.
K090630	NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)	Jun 02, 2009	Substantially Equivalent	Nobel Biocare AB
K071018	MONARCH NASAL IMPLANT	May 25, 2007	Substantially Equivalent	Hanson Medical, Inc.
K041690	MONARCH NASAL IMPLANT	Feb 11, 2005	Substantially Equivalent	Hanson Medical, Inc.
K021418	AART NASAL IMPLANT	Jul 02, 2002	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.
K992242	PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS	Nov 22, 1999	Substantially Equivalent	Pillar Surgical, Inc.
K983755	NASAL DORSAL SERIES	Nov 20, 1998	Substantially Equivalent	Surgical Technology Laboratories, Inc.
K982753	SEARE BIOMEDICAL NASAL IMPLANTS	Sep 30, 1998	Substantially Equivalent	Seare Biomedical Corp.
K981833	SILIMED NASAL L SHAPED IMPLANT	Jun 26, 1998	Substantially Equivalent	Silimed, LLC
K973573	DURALASTIC ANATOMICAL NASAL IMPLANTS	Nov 13, 1997	Substantially Equivalent	Hanson Medical, Inc.
K971481	DURALASTIC ANATOMICAL NASAL IMPLANTS	Jul 18, 1997	Substantially Equivalent	Allied Biomedical Corp.
K962824	IMPLANTECH JEJ PERI-PYRIFORM IMPLANT	Oct 03, 1996	Substantially Equivalent	Implantech Associates, Inc.
K961124	THE NAUTILUS	Apr 19, 1996	Substantially Equivalent	Rand Scientific Corp.
K952709	PROTHESIS, CHIN, INTERNAL	Aug 28, 1995	Substantially Equivalent	Spirit Ridge Technologies
K952708	PECTORALIS IMPLANT	Aug 28, 1995	Substantially Equivalent	Spirit Ridge Technologies
K952707	SILICONE ELASTOMER MALAR IMPLANT	Aug 28, 1995	Substantially Equivalent	Spirit Ridge Technologies
K952706	SPIRIT RIDGE SILICONE CARVING BLOCK	Aug 28, 1995	Substantially Equivalent	Spirit Ridge Technologies
K952705	SPIRIT RIDGE NASAL IMPLANT	Aug 28, 1995	Substantially Equivalent	Spirit Ridge Technologies
K945154	BA-CPAS	Jan 13, 1995	Substantially Equivalent	Nobelpharma USA, Inc.
K941960	IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II	Aug 17, 1994	Substantially Equivalent	Implantech Associates, Inc.
K942876	IMPLANTECH DORSAL NASAL IMPLANT	Jul 18, 1994	Substantially Equivalent	Implantech Associates, Inc.
K925743	NASAL DORSUM	Aug 10, 1993	Substantially Equivalent	Smith & Nephew Richards, Inc.
K925426	RIZZO NASAL IMPLANT	May 12, 1993	Substantially Equivalent	Implantech Associates, Inc.
K921580	BRINK PRE-MAXILLARY IMPLANT	May 06, 1992	Substantially Equivalent	Implantech Associates, Inc.
K904657	FLOWERS DORSAL COLUMELLA IMPLANT	Dec 18, 1990	Substantially Equivalent	Implantech Associates, Inc.
K904656	FLOWERS NASAL IMPLANT	Dec 18, 1990	Substantially Equivalent	Implantech Associates, Inc.
K904350	CUI DORSAL COLUMELLA PROSTHESIS	Nov 26, 1990	Substantially Equivalent	Cui Corp.
K903328	CUI PREMAXILLARY IMPLANT	Sep 10, 1990	Substantially Equivalent	Cui Corp.
K902283	THE NAUTILUS NASAL IMPLANT	Aug 14, 1990	Substantially Equivalent	Applied Biomaterial Technologies
K880405	SILASTIC NASAL IMPLANT S-TYPE	Feb 18, 1988	Substantially Equivalent	Dow Corning Wright
K871071	OMEGA DORSAL COLUMELLA IMPLANTS	Apr 13, 1987	Substantially Equivalent	Omega Silicone, Inc.
K863942	POREX(TM) NOSE PROSTHESIS	Oct 24, 1986	Substantially Equivalent	Porex Medical
K863430	BYRON BIVALVE NASAL SPLINTS	Sep 17, 1986	Substantially Equivalent	Byron Medical
K863399	BYRON DORSAL COLUMELLA IMPLANT	Sep 17, 1986	Substantially Equivalent	Byron Medical
K863398	BYRON NASAL SEPTAL BUTTON	Sep 17, 1986	Substantially Equivalent	Byron Medical
K853945	CUI RHINOPLASTY IMPLANTS	Oct 18, 1985	Substantially Equivalent	Cox-Uphuff Intl.
K822130	FRANCIS NASAL TUBE	Oct 13, 1982	Substantially Equivalent	Tekna Med Corp.
K801074	STRAITH NASAL IMPLANT	Jun 17, 1980	Substantially Equivalent	Surgical Technology Laboratories, Inc.
K782104	PASTE, PRO CARE PROPHYLAXIS	Jan 03, 1979	Substantially Equivalent	Young Dental Manufacturing Co. 1, LLC
K781574	PLASTI-PORE SEPTAL BUTTON	Sep 27, 1978	Substantially Equivalent	Richard'S Medical Equip., Inc.