Silicone Block- Rectangular
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Silicone Block- Rectangular FDA UDI
- Generic Name
- Silicone-block tissue reconstructive material FDA UDI
- Device Name
- Silicone Block, 40 Durometer FDA UDI
- Model / Reference
- Silicone Facial Implant EUDAMEDBLK-40-NS EUDAMEDSize: 12.0cm x 7.0cm x 1.5cm FDA UDI
- Description
- Silicone Block, 40 Durometer FDA UDI
Identifiers
- Catalog Number
- BLK-40-NS FDA UDI
- Primary DI / UDI-DI
- M724BLK40NS1 EUDAMEDFDA UDI
- Basic UDI-DI
- B-M724BLK40NS1 EUDAMED
- 510(k) Number
- K913882 FDA UDI
- FDA Product Code
- MIB FDA UDI
- EMDN Code
- P010199 FACIAL PROSTHESES - OTHER EUDAMED
- GMDN Term
- Silicone-block tissue reconstructive material FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3620 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Silicone-block tissue reconstructive material
Silicone Block- Rectangular by Implantech Associates, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Silicone-block tissue reconstructive material.
- Gluteal Implant — Aart · Class II
- Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
- Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
- Calf Implant — Aart · Class II
- Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
- Gluteal Implant — Hanson Medical, Inc. · Class II
- Silicone Block — International Medical Devices, Inc. · Class II
- Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
Cleared under the same submission
K913882 also covers:
- Rectangular Carving Block 2.0 — Implantech Associates, Inc.
- Rectangular Carving Block 2.0 — Implantech Associates, Inc.
- Rectangular Carving Block 2.0 — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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
- Implantech Associates, Inc.
Sources (2)
- FDA UDI c0eac6e5-30da-4269-986b-facb0a501462 36 fields · synced Jul 11, 2026
- EUDAMED a6580d86-4fb8-42df-a02e-41241314a57d 61 fields · synced Jul 11, 2026