Identity
- Trade Name
- ePTFE Forehead FDA UDI
- Generic Name
- Silicone-block tissue reconstructive material FDA UDI
- Device Name
- Forehead Implant FDA UDI
- Model / Reference
- Sze: Large FDA UDI
- Description
- Forehead Implant FDA UDI
Identifiers
- Catalog Number
- ESFH-L FDA UDI
- Primary DI / UDI-DI
- M724ESFHL1 FDA UDI
- 510(k) Number
- K141027 FDA UDI
- FDA Product Code
- FWP FDA UDI
- GMDN Term
- Silicone-block tissue reconstructive material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3550 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
Yes
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
ePTFE Forehead by Implantech Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Silicone-block tissue reconstructive material.
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- Silicone Block — International Medical Devices, Inc. · Class II
- Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
Cleared under the same submission
K141027 also covers:
- Silicone Sizer Set for ePTFE Extended Chin — Implantech Associates, Inc.
- Silicone Sizer Set for ePTFE Forehead — Implantech Associates, Inc.
- Silicone Sizer Set for ePTFE Midfacial — Implantech Associates, Inc.
- Silicone Sizer Set for ePTFE Nasal Dorsum, Pointed — Implantech Associates, Inc.
- Silicone Sizer Set for ePTFE Nasal Dorsum, Rounded — Implantech Associates, Inc.
- Silicone Sizer Set for ePTFE Paranasal — Implantech Associates, Inc.
- Silicone Sizer Set for ePTFE Premaxillary — Implantech Associates, Inc.
- Solid ePTFE Nasal Dorsum, T Implant — Implantech Associates, Inc.
- Solid ePTFE Nasal Dorsum, T Implant — Implantech Associates, Inc.
- Solid ePTFE Nasal L Implant — Implantech Associates, Inc.
- Solid ePTFE Nasal L Implant — Implantech Associates, Inc.
- Solid ePTFE Paranasal, Flat Top — Implantech Associates, Inc.
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 |
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Manufacturer
- Manufacturer
- Implantech Associates, Inc.
Sources (1)
- FDA UDI d4763757-1d9e-418c-88eb-c493dc6e5fa4 36 fields · synced Jun 9, 2026