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Lateral Mandibular Angle™

FDA UDI

Class II (US FDA UDI)

by Implantech Associates, Inc.

Identity

Trade Name
Lateral Mandibular Angle™ FDA UDI
Generic Name
Facial mandibular prosthesis FDA UDI
Device Name
Mandibular Implant FDA UDI
Model / Reference
Size: 4/12, Right FDA UDI
Description
Mandibular Implant FDA UDI

Identifiers

Catalog Number
TMA-04-12R-NS FDA UDI
Primary DI / UDI-DI
M724TMA0412RNS1 FDA UDI
510(k) Number
K905268 FDA UDI
FDA Product Code
FWP FDA UDI
GMDN Term
Facial mandibular 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Facial mandibular prosthesis

Lateral Mandibular Angle™ by Implantech Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Facial mandibular prosthesis.

Cleared under the same submission

K905268 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 4b4c585e-9847-4094-8735-bf223e090575 36 fields · synced Jun 9, 2026