Identity
- Trade Name
- Chin Implant FDA UDI
- Generic Name
- Chin prosthesis FDA UDI
- Device Name
- Non-sterile, silicone, chin implant, sizer. FDA UDI
- Model / Reference
- CH 13-4 S FDA UDI
- Description
- Non-sterile, silicone, chin implant, sizer. FDA UDI
Identifiers
- Catalog Number
- CH 13-4 S FDA UDI
- Primary DI / UDI-DI
- B049CH134S0 FDA UDI
- 510(k) Number
- K973575 FDA UDI
- FDA Product Code
- FWP FDA UDI
- GMDN Term
- Chin prosthesis 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Chin prosthesis
Chin Implant by Hanson Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chin prosthesis.
- Terino Square Chin-Style II — Implantech Associates, Inc. · Class II
- Extended Anatomical Chin — Implantech Associates, Inc. · Class II
- Chin Implant — Implantech Associates, Inc. · Class II
- MEDPOR — Stryker Leibinger · Class II
- Conform™ Extended Anatomical Chin — Implantech Associates, Inc. · Class II
- Bilateral Groove Chin — Implantech Associates, Inc. · Class II
- 900-009 Mittleman Geniomandibular Groove Jowl Sizer Set — Implantech Associates, Inc. · Class II
- Mittleman Geniomandibular Groove Jowl — Implantech Associates, Inc. · Class II
Cleared under the same submission
K973575 also covers:
- Chin Implant — Hanson Medical, Inc.
- Chin Implant — Hanson Medical, Inc.
- Chin Implant — Hanson Medical, Inc.
- Chin Implant — Hanson Medical, Inc.
- Chin Implant — Hanson Medical, Inc.
- Chin Implant — Hanson Medical, Inc.
- Chin Implant — Hanson Medical, Inc.
- Chin Implant — Hanson Medical, Inc.
- Chin Implant — Hanson Medical, Inc.
- Chin Implant — Hanson Medical, Inc.
- Chin Implant — Hanson Medical, Inc.
- Chin Implant — Hanson Medical, 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
- Hanson Medical, Inc.
Sources (1)
- FDA UDI 404d75b7-2ae8-44f7-8baf-a32743952f85 36 fields · synced Jun 9, 2026