Product Code: MIB FDA class 2 21 CFR 874.3620

Elastomer, Silicone Block

Ear, Nose, Throat

The Silicone Block Elastomer is a solid silicone material used as a building block or filler implant in otolaryngology and head-and-neck reconstructive surgery, such as augmenting or reconstructing soft tissue structures in the ear, nose, or throat regions. Classified as a Class 2 implantable device under 21 CFR 874.3620 within the Ear, Nose, and Throat specialty, it requires 510(k) premarket notification. It carries an implant flag, indicating it is intended to be placed inside the body.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MIB
Device Class: FDA class 2
Regulation Number: 874.3620
Medical Specialty: Ear, Nose, Throat
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 45 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241150	MISTI Silicone Implant	Jul 24, 2024	Substantially Equivalent	Keosan Trading Co.
K223051	Pre-Formed Silicone Block	Feb 03, 2023	Substantially Equivalent	International Medical Devices, Inc.
K222748	ShiNeo Silicone Implant	Dec 23, 2022	Substantially Equivalent	Shineo Technology Co., Ltd.
K200073	AugMENTA Penile Implant	Sep 30, 2022	Substantially Equivalent	Augmenta, LLC
K220760	Pre-Formed Penile Silicone Block	May 13, 2022	Substantially Equivalent	International Medical Devices, Inc.
K193392	BioSiCar Silicone Implant	Jul 20, 2020	Substantially Equivalent	Metalware Technology Corp.
K181387	Pre-Formed Penile Silicone Block	Jan 23, 2019	Substantially Equivalent	International Medical Devices, Inc.
K171851	SOFTXIL	Mar 16, 2018	Substantially Equivalent	Bistool
K162624	Pre-Formed Penile Silicone Block	Feb 01, 2017	Substantially Equivalent	International Medical Devices, Inc.
K052505	CALF IMPLANT, MODEL EC17-X	Nov 04, 2005	Substantially Equivalent	Implantech Associates, Inc.
K052504	GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X	Nov 04, 2005	Substantially Equivalent	Implantech Associates, Inc.
K042054	SILIMED PECTORAL IMPLANT	Feb 23, 2005	Substantially Equivalent	Silimed, Inc.
K042380	SILICONE BLOCK	Oct 25, 2004	Substantially Equivalent	National Medical Devices, Inc.
K040042	MEDISIL SILICONE SHEETING	Apr 01, 2004	Substantially Equivalent	Medisil Corporation
K030809	HANSON MEDICAL GLUTEAL IMPLANT	Apr 21, 2003	Substantially Equivalent	Hanson Medical, Inc.
K030808	HANSON MEDICAL CALF IMPLANT	Apr 21, 2003	Substantially Equivalent	Hanson Medical, Inc.
K022511	AART CALF IMPLANT	Aug 26, 2002	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.
K022223	AART SILICONE SHEETING	Aug 08, 2002	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.
K021839	AART GLUTEAL IMPLANT	Jul 16, 2002	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.
K021820	AART SILICONE CARVING BLOCK	Jul 16, 2002	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.
K983630	SEARE BIOMEDICAL SILICONE RODS	Dec 11, 1998	Substantially Equivalent	Seare Biomedical Corp.
K982688	SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK	Oct 13, 1998	Substantially Equivalent	Spectrum Designs, Inc.
K983041	SEARE BIOMEDICAL SILICONE SHEETING	Sep 30, 1998	Substantially Equivalent	Seare Biomedical Corp.
K982065	STERILE SILICONE EXTERNAL WOUND COVER	Aug 12, 1998	Substantially Equivalent	Specialty Surgical Products, Inc.
K981851	SILIMED SILICONE CARVING BLOCK	Jul 09, 1998	Substantially Equivalent	Silimed, LLC
K974653	SILICONE ELASTOMER SHEETING	Mar 13, 1998	Substantially Equivalent	Specialty Surgical Products, Inc.
K974654	SILICONE BLOCKS	Feb 24, 1998	Substantially Equivalent	Specialty Surgical Products, Inc.
K974482	SILIMED GLUTEAL IMPLANT	Feb 24, 1998	Substantially Equivalent	Silimed, LLC
K974480	SILIMED CALF IMPLANT	Feb 24, 1998	Substantially Equivalent	Silimed, LLC
K973730	DURASIL I AND DURASIL II	Dec 24, 1997	Substantially Equivalent	Hanson Medical, Inc.
K973166	DOW CORNING SILASTIC ELASTOMER Q7-4750	Nov 21, 1997	Substantially Equivalent	Technical Products, Inc.
K973728	SILICONE CARVING BLOCK	Nov 13, 1997	Substantially Equivalent	Hanson Medical, Inc.
K971480	DURALASTIC I AND DURALASTIC II	May 28, 1997	Substantially Equivalent	Allied Biomedical Corp.
K971613	SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING	May 22, 1997	Substantially Equivalent	Technical Products, Inc.
K961081	SPIRIT RIDGE SILICONE CARVING BLOCK	May 22, 1996	Substantially Equivalent	Rand Scientific Corp.
K961057	DURALASTIC SHEETING II	May 16, 1996	Substantially Equivalent	Rand Scientific Corp.
K960038	SPECTRUM DESIGNS SILICONE BLOCK	Mar 13, 1996	Substantially Equivalent	Spectrum Designs, Inc.
K955370	DURALASTIC II	Feb 08, 1996	Substantially Equivalent	Allied Biomedical Corp.
K955368	DURALASTIC I	Feb 08, 1996	Substantially Equivalent	Allied Biomedical Corp.
K954382	PROLASTIC SHEETING	Nov 29, 1995	Substantially Equivalent	Pillar Surgical
K952732	MEDICAL GRADE SILICONE BLOCK	Aug 31, 1995	Substantially Equivalent	Bioplexus Corp.
K945552	DURALASTIC SHEETING	Jan 31, 1995	Substantially Equivalent	Applied Biomaterial Technologies
K935571	DURALASTIC SHEETING	Jan 31, 1995	Substantially Equivalent	Applied Biomaterial Technologies
K944408	IMPLANTECH MEDICAL GRADE SILICONE SHEETING	Nov 09, 1994	Substantially Equivalent	King & Spalding
K913882	ZARA SILICONE BLOCK	Apr 21, 1992	Substantially Equivalent	Byron Medical