Duralastic Sheeting
FDA 510(k) K945552 · Applied Biomaterial Technologies
510(k) numberK945552
Submission
- Device name
- Duralastic Sheeting
- Applicant
- Applied Biomaterial Technologies
Silverdale, WA, US - Received
- November 10, 1994
- Decision date
- January 31, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MIB – Elastomer, Silicone Block
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
Other 510(k)s with product code MIB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241150 | MISTI Silicone ImplantMIB · Traditional | Keosan Trading Co. | 07/24/2024SE |
| K223051 | Pre-Formed Silicone BlockMIB · Traditional | International Medical Devices, Inc. | 02/03/2023SE |
| K222748 | ShiNeo Silicone ImplantMIB · Traditional | Shineo Technology Co., Ltd. | 12/23/2022SE |
| K200073 | AugMENTA Penile ImplantMIB · Traditional | Augmenta, LLC | 09/30/2022SE |
| K220760 | Pre-Formed Penile Silicone BlockMIB · Traditional | International Medical Devices, Inc. | 05/13/2022SE |
| K193392 | BioSiCar Silicone ImplantMIB · Traditional | Metalware Technology Corp. | 07/20/2020SE |
| K181387 | Pre-Formed Penile Silicone BlockMIB · Traditional | International Medical Devices, Inc. | 01/23/2019SE |
| K171851 | SoftxilMIB · Traditional | Bistool | 03/16/2018SE |
| K162624 | Pre-Formed Penile Silicone BlockMIB · Traditional | International Medical Devices, Inc. | 02/01/2017SE |
| K052505 | Calf Implant, Model EC17-XMIB · Traditional | Implantech Associates, Inc. | 11/04/2005SE |
More from Implantech Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K935571 | Duralastic SheetingMIB · Traditional | 01/31/1995SE |
| K931500 | The Permaridge Matrix ChinFWP · Traditional | 11/17/1994SE |
| K913768 | Pec ImplantMIC · Traditional | 02/03/1992SE |
| K902285 | The Magnum Chin ImplantFWP · Traditional | 09/12/1990SE |
| K902284 | Zymalar ImplantLZK · Traditional | 09/12/1990SE |
| K902283 | The Nautilus Nasal ImplantFZE · Traditional | 08/14/1990SE |
Questions and answers
When was Duralastic Sheeting cleared by the FDA?
Duralastic Sheeting (K945552) received a 510(k) decision of Substantially Equivalent on January 31, 1995, 82 days after the submission was received.
What is the product code of K945552?
The FDA product code is MIB – Elastomer, Silicone Block, a Class II (moderate risk) device regulated under 21 CFR 874.3620.