Identity
- Trade Name
- Composite™ ePTFE-Coated Auricular Base Frame FDA UDI
- Generic Name
- External ear prosthesis, implantable FDA UDI
- Device Name
- Auricular Implant FDA UDI
- Model / Reference
- Size 55, Right FDA UDI
- Description
- Auricular Implant FDA UDI
Identifiers
- Catalog Number
- EPTFE-ABF-55R FDA UDI
- Primary DI / UDI-DI
- M724EPTFEABF55R1 FDA UDI
- 510(k) Number
- K172389 FDA UDI
- FDA Product Code
- FZD FDA UDI
- GMDN Term
- External ear prosthesis, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3590 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: External ear prosthesis, implantable
Composite™ ePTFE-Coated Auricular Base Frame by Implantech Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as External ear prosthesis, implantable.
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- OmniPore Surgical Implant — MATRIX SURGICAL HOLDINGS, LLC · Class II
- MEDPOR — Stryker Leibinger · Class II
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Cleared under the same submission
K172389 also covers:
- Composite™ ePTFE- Coated Auricular Anti-Helix — Implantech Associates, Inc.
- Composite™ ePTFE-Coated Auricular Anti-Helix — Implantech Associates, Inc.
- Composite™ ePTFE-Coated Auricular Anti-Helix — Implantech Associates, Inc.
- Composite™ ePTFE-Coated Auricular Anti-Helix — Implantech Associates, Inc.
- Composite™ ePTFE-Coated Auricular Anti-Helix — Implantech Associates, Inc.
- Composite™ ePTFE-Coated Auricular Anti-Helix — Implantech Associates, Inc.
- Composite™ ePTFE-Coated Auricular Anti-Helix — Implantech Associates, Inc.
- Composite™ ePTFE-Coated Auricular Anti-Helix — Implantech Associates, Inc.
- Composite™ ePTFE-Coated Auricular Base Frame — Implantech Associates, Inc.
- Composite™ ePTFE-Coated Auricular Base Frame — Implantech Associates, Inc.
- Composite™ ePTFE-Coated Auricular Base Frame — Implantech Associates, Inc.
- Composite™ ePTFE-Coated Auricular Base Frame — 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 e84d5d9f-07fe-4962-871c-d654c596e1cf 36 fields · synced Jun 9, 2026