Data / Medical devices / Elastomer, Silicone Block
Elastomer, Silicone Block (MIB): 9 FDA-registered makers in 2 countries
9 establishments in 2 countries are registered with the FDA to make Elastomer, Silicone Block (product code MIB, Class 2, 21 CFR 874.3620). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 45 510(k) clearances under this code, the latest on July 24, 2024, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MIB
- Device class
- 2
- Regulation
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| South Korea | 1 |
Makers of Elastomer, Silicone Block
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Implantech Associates, Inc. | Ventura, CA, United States | Contract manufacturer, Manufacturer | 6 | November 4, 2005 | 0 | 0 | 0 | api.fda.gov |
| Dsaart, LLC | Carson City, NV, United States | Manufacturer | 4 | August 26, 2002 | 0 | 1 | 0 | api.fda.gov |
| Hanson Medical, Inc. | Paso Robles, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 3 | April 21, 2003 | 0 | 0 | 0 | api.fda.gov |
| Technical Products, Inc. | Buford, GA, United States | Manufacturer, Repackager or relabeler | 3 | November 21, 1997 | 0 | 0 | 0 | api.fda.gov |
| International Medical Devices, Inc | Beverly Hills, CA, United States | Complaint file establishment, Specification developer | 2 | May 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| Bistool Inc | Seoul, South Korea | Manufacturer | 1 | March 16, 2018 | 0 | 0 | 0 | api.fda.gov |
| Bentec Medical OpCo, LLC. | Woodland, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Grace Medical, Inc. | Memphis, TN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kuro Medical | Eden Prairie, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 24, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.