Spectrum Designs Medical

FDA UDI

Class II (US FDA UDI)

by Spectrum Designs, Inc.

Identity

Trade Name: Spectrum Designs Medical FDA UDI
Generic Name: Chin prosthesis FDA UDI
Model / Reference: Anatomical Chin, size 1 FDA UDI

Identifiers

Catalog Number: S250-114S FDA UDI
Primary DI / UDI-DI: B018S250114S1 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Chin prosthesis

Spectrum Designs Medical by Spectrum Designs, 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
Chin Implant — Hanson Medical, Inc. · Class II
Bilateral Groove Chin — Implantech Associates, Inc. · Class II
900-009 Mittleman Geniomandibular Groove Jowl Sizer Set — Implantech Associates, Inc. · Class II

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: Spectrum Designs, Inc.

Sources (1)

FDA UDI b3a0f9c9-586e-4ca3-9b97-57dd04e81f13 34 fields · synced Jun 1, 2026