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Profile Malar

FDA UDI

Class II (US FDA UDI)

by Implantech Associates, Inc.

Identity

Trade Name
Profile Malar FDA UDI
Generic Name
Malar prosthesis FDA UDI
Device Name
Malar Implant FDA UDI
Model / Reference
Size 2 FDA UDI
Description
Malar Implant FDA UDI

Identifiers

Catalog Number
140-424S FDA UDI
Primary DI / UDI-DI
M724140424S1 FDA UDI
510(k) Number
K980139 FDA UDI
FDA Product Code
LZK FDA UDI
GMDN Term
Malar 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: Malar prosthesis

Profile Malar by Implantech Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Malar prosthesis.

Cleared under the same submission

K980139 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Implantech Associates, Inc.

Sources (1)

  • FDA UDI 91ba3c62-a0f7-410b-8f6d-0c2b658ae383 36 fields · synced Jun 9, 2026