Identity
- Trade Name
- Silicone Blocks FDA UDI
- Generic Name
- Silicone-block tissue reconstructive material FDA UDI
- Model / Reference
- PR88032-21 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00684995200050 FDA UDI
- 510(k) Number
- K840172 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Silicone-block tissue reconstructive material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Silicone-block tissue reconstructive material
Silicone Blocks by Bentec Medical OpCo, LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silicone-block tissue reconstructive material.
- SG Gluteal Implant — Implantech Associates, Inc. · Class II
- Gluteal Implant — Aart · Class II
- Contoured Carving Block — Implantech Associates, Inc. · Class II
- ContourFlex™ Calf Implant Sizer — Implantech Associates, Inc. · Class II
- Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
- Powerflex™ Pectoral Implant — Implantech Associates, Inc. · Class II
- SG Pec Sizer — Implantech Associates, Inc. · Class II
- SG Pec Implant Style 4 — Implantech Associates, Inc. · Class II
Cleared under the same submission
K840172 also covers:
- Silicone Blocks — Bentec Medical OpCo, LLC.
- Silicone Blocks — Bentec Medical OpCo, LLC.
- Silicone Blocks — Bentec Medical OpCo, LLC.
- Silicone Blocks — Bentec Medical OpCo, LLC.
- Silicone Blocks — Bentec Medical OpCo, LLC.
- Silicone Blocks — Bentec Medical OpCo, LLC.
- Silicone Blocks — Bentec Medical OpCo, LLC.
- Silicone Sheeting Non-Reinforced — Bentec Medical OpCo, LLC.
- Silicone Sheeting Non-Reinforced — Bentec Medical OpCo, LLC.
- Silicone Sheeting Non-Reinforced — Bentec Medical OpCo, LLC.
- Silicone Sheeting Non-Reinforced — Bentec Medical OpCo, LLC.
- Silicone Sheeting Non-Reinforced — Bentec Medical OpCo, LLC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bentec Medical OpCo, LLC.
Sources (1)
- FDA UDI d4479545-6a28-4957-86aa-8b07d44e04f4 33 fields · synced May 31, 2026