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Chin Implant

FDA UDI

Class II (US FDA UDI)

by Hanson Medical, Inc.

Identity

Trade Name
Chin Implant FDA UDI
Generic Name
Chin prosthesis FDA UDI
Device Name
Sterile, silicone, chin implant. FDA UDI
Model / Reference
SCH 14-3 FDA UDI
Description
Sterile, silicone, chin implant. FDA UDI

Identifiers

Catalog Number
SCH 14-3 FDA UDI
Primary DI / UDI-DI
B049SCH1430 FDA UDI
510(k) Number
K090803 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

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: 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.

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 90c9a670-fe7f-489c-a24c-ea9ecd431aae 36 fields · synced Jun 9, 2026