Identity
- Trade Name
- MENTOR SILTEX Round Moderate Profile FDA UDI
- Generic Name
- Saline-filled breast implant, unstructured, textured-surface FDA UDI
- Device Name
- Saline Breast Implant with Diaphragm Valve, 425cc FDA UDI
- Model / Reference
- 3542670 FDA UDI
- Description
- Saline Breast Implant with Diaphragm Valve, 425cc FDA UDI
Identifiers
- Catalog Number
- 354-2670 FDA UDI
- Primary DI / UDI-DI
- 00081317001829 FDA UDI
- PMA Number
- P990075 FDA UDI
- FDA Product Code
- FWM FDA UDI
- GMDN Term
- Saline-filled breast implant, unstructured, textured-surface FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 878.3530 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MENTOR SILTEX Round Moderate Profile by Mentor Texas LP — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P990075 also covers:
- MENTOR Diaphragm Valve Fill Tube — Mentor Texas LP
- MENTOR Diaphragm Valve Fill Tube LONG 61cm 24in — Mentor Texas LP
- MENTOR Diaphragm Valve Fill Tube LONG 61cm 24in with 45 Degree Connector — Mentor Texas LP
- MENTOR Smooth Round High Profile — Mentor Texas LP
- MENTOR Smooth Round High Profile — Mentor Texas LP
- MENTOR Smooth Round High Profile — Mentor Texas LP
- MENTOR Smooth Round High Profile — Mentor Texas LP
- MENTOR Smooth Round High Profile — Mentor Texas LP
- MENTOR Smooth Round High Profile — Mentor Texas LP
- MENTOR Smooth Round High Profile — Mentor Texas LP
- MENTOR Smooth Round Moderate Plus Profile — Mentor Texas LP
- MENTOR Smooth Round Moderate Plus Profile — Mentor Texas LP
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 III | Pending data |
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Manufacturer
- Manufacturer
- Mentor Texas LP
Sources (1)
- FDA UDI 63ad3365-a539-49fd-ba3a-7115727c1580 37 fields · synced Jun 1, 2026