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Posterior Mandibular Angle™

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref TMA-4LModel Silicone Facial Implant

by Implantech Associates, Inc.

Identity

Trade Name
Posterior Mandibular Angle™ FDA UDI
Generic Name
Facial mandibular prosthesis FDA UDI
Device Name
Mandibular Implant FDA UDI
Model / Reference
Silicone Facial Implant EUDAMED
TMA-4L EUDAMED
Size 4, Left FDA UDI
Description
Mandibular Implant FDA UDI

Identifiers

Catalog Number
TMA-4L FDA UDI
Primary DI / UDI-DI
M724TMA4L1 EUDAMEDFDA UDI
Basic UDI-DI
B-M724TMA4L1 EUDAMED
FDA Product Code
FWP FDA UDI
EMDN Code
P010101 CHIN PROSTHESES EUDAMED
GMDN Term
Facial mandibular prosthesis FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
878.3550 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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: Facial mandibular prosthesis

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

Similar devices

Also classified as Facial mandibular prosthesis.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Implantech Associates, Inc.

Sources (2)

  • FDA UDI 3a2af6a3-d247-472a-a15b-08e7ab102a17 35 fields · synced Jun 19, 2026
  • EUDAMED 50982d29-188f-474d-86ff-7c8e64dc711d 61 fields · synced Jun 19, 2026