Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

FZE — Predicate Candidate Screening

42 FDA 510(k) clearances under this product code; the 50 most recent screened below.

64 daysmedian FDA review time

197 days90th percentile

42clearances measured

K-number	Device	Applicant	Decided	Review days
K241253	Medicon Epiplating System	Cmf Medicon Surgical, Inc.	2024-12-12	223
K161548	Osseointegrated Fixtures	Southern Implants (Pty), Ltd.	2016-12-01	181
K090803	HANSON MEDICAL FACIAL IMPLANTS	Hanson Medical, Inc.	2010-06-30	463
K090630	NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)	Nobel Biocare AB	2009-06-02	85
K071018	MONARCH NASAL IMPLANT	Hanson Medical, Inc.	2007-05-25	45
K041690	MONARCH NASAL IMPLANT	Hanson Medical, Inc.	2005-02-11	234
K021418	AART NASAL IMPLANT	Aesthetic and Reconstructive Technologies, Inc.	2002-07-02	60
K992242	PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS	Pillar Surgical, Inc.	1999-11-22	143
K983755	NASAL DORSAL SERIES	Surgical Technology Laboratories, Inc.	1998-11-20	29
K982753	SEARE BIOMEDICAL NASAL IMPLANTS	Seare Biomedical Corp.	1998-09-30	55
K981833	SILIMED NASAL L SHAPED IMPLANT	Silimed, LLC	1998-06-26	31
K973573	DURALASTIC ANATOMICAL NASAL IMPLANTS	Hanson Medical, Inc.	1997-11-13	55
K971481	DURALASTIC ANATOMICAL NASAL IMPLANTS	Allied Biomedical Corp.	1997-07-18	86
K962824	IMPLANTECH JEJ PERI-PYRIFORM IMPLANT	Implantech Associates, Inc.	1996-10-03	76
K961124	THE NAUTILUS	Rand Scientific Corp.	1996-04-19	29
K952707	SILICONE ELASTOMER MALAR IMPLANT	Spirit Ridge Technologies	1995-08-28	75
K952709	PROTHESIS, CHIN, INTERNAL	Spirit Ridge Technologies	1995-08-28	75
K952706	SPIRIT RIDGE SILICONE CARVING BLOCK	Spirit Ridge Technologies	1995-08-28	75
K952708	PECTORALIS IMPLANT	Spirit Ridge Technologies	1995-08-28	75
K952705	SPIRIT RIDGE NASAL IMPLANT	Spirit Ridge Technologies	1995-08-28	75
K945154	BA-CPAS	Nobelpharma USA, Inc.	1995-01-13	84
K941960	IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II	Implantech Associates, Inc.	1994-08-17	117
K942876	IMPLANTECH DORSAL NASAL IMPLANT	Implantech Associates, Inc.	1994-07-18	31
K925743	NASAL DORSUM	Smith & Nephew Richards, Inc.	1993-08-10	270
K925426	RIZZO NASAL IMPLANT	Implantech Associates, Inc.	1993-05-12	197
K921580	BRINK PRE-MAXILLARY IMPLANT	Implantech Associates, Inc.	1992-05-06	34
K904656	FLOWERS NASAL IMPLANT	Implantech Associates, Inc.	1990-12-18	64
K904657	FLOWERS DORSAL COLUMELLA IMPLANT	Implantech Associates, Inc.	1990-12-18	64
K904350	CUI DORSAL COLUMELLA PROSTHESIS	Cui Corp.	1990-11-26	63
K903328	CUI PREMAXILLARY IMPLANT	Cui Corp.	1990-09-10	47
K902283	THE NAUTILUS NASAL IMPLANT	Applied Biomaterial Technologies	1990-08-14	84
K880405	SILASTIC NASAL IMPLANT S-TYPE	Dow Corning Wright	1988-02-18	20
K871071	OMEGA DORSAL COLUMELLA IMPLANTS	Omega Silicone, Inc.	1987-04-13	26
K863942	POREX(TM) NOSE PROSTHESIS	Porex Medical	1986-10-24	14
K863430	BYRON BIVALVE NASAL SPLINTS	Byron Medical	1986-09-17	13
K863399	BYRON DORSAL COLUMELLA IMPLANT	Byron Medical	1986-09-17	14
K863398	BYRON NASAL SEPTAL BUTTON	Byron Medical	1986-09-17	14
K853945	CUI RHINOPLASTY IMPLANTS	Cox-Uphuff Intl.	1985-10-18	24
K822130	FRANCIS NASAL TUBE	Tekna Med Corp.	1982-10-13	86
K801074	STRAITH NASAL IMPLANT	Surgical Technology Laboratories, Inc.	1980-06-17	42
K782104	PASTE, PRO CARE PROPHYLAXIS	Young Dental Manufacturing Co. 1, LLC	1979-01-03	15
K781574	PLASTI-PORE SEPTAL BUTTON	Richard'S Medical Equip., Inc.	1978-09-27	9

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda