Lateral Mandibular Angle™
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Lateral Mandibular Angle™ FDA UDI
- Generic Name
- Facial mandibular prosthesis FDA UDI
- Device Name
- Mandibular Implants FDA UDI
- Model / Reference
- Silicone Facial Implant EUDAMEDTMA-4R/8 EUDAMEDSize 4/8, Right FDA UDI
- Description
- Mandibular Implants FDA UDI
Identifiers
- Catalog Number
- TMA-4R/8 FDA UDI
- Primary DI / UDI-DI
- M724TMA4R81 EUDAMEDFDA UDI
- Basic UDI-DI
- B-M724TMA4R81 EUDAMED
- 510(k) Number
- K905268 FDA UDI
- FDA Product Code
- FWP FDA UDI
- EMDN Code
- P010101 CHIN PROSTHESES EUDAMED
- GMDN Term
- Facial mandibular prosthesis FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass 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
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Facial mandibular prosthesis
Lateral 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.
- Posterior Mandibular Angle™ — Implantech Associates, Inc. · Class II
- Vertical Mandibular Angle™ — Implantech Associates, Inc. · Class II
- Conform Mandibular Angle™ — Implantech Associates, Inc. · Class II
- Widening Mandibular Angle™ — Implantech Associates, Inc. · Class II
- Lateral Mandibular Angle™ Sizers — Implantech Associates, Inc. · Class II
- Posterior Mandibular Angle™ — Implantech Associates, Inc. · Class II
- Widening Mandibular Angle™ — Implantech Associates, Inc. · Class II
- Vertical Mandibular Angle™ — Implantech Associates, Inc. · Class II
Cleared under the same submission
K905268 also covers:
- Conform Mandibular Angle™ — Implantech Associates, Inc.
- Conform Mandibular Angle™ — Implantech Associates, Inc.
- Conform Mandibular Angle™ — Implantech Associates, Inc.
- Conform Mandibular Angle™ — Implantech Associates, Inc.
- Conform Mandibular Angle™ — Implantech Associates, Inc.
- Conform Mandibular Angle™ — Implantech Associates, Inc.
- Conform Mandibular Angle™ — Implantech Associates, Inc.
- Conform Mandibular Angle™ — Implantech Associates, Inc.
- Conform Mandibular Angle™ — Implantech Associates, Inc.
- Flowers Mandibular Glove® — Implantech Associates, Inc.
- Flowers Mandibular Glove® — Implantech Associates, Inc.
- Flowers Mandibular Glove® — Implantech Associates, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Implantech Associates, Inc.
Sources (2)
- FDA UDI cd9bdadd-28b5-4ef2-9ea4-573e8752b7eb 36 fields · synced Jul 9, 2026
- EUDAMED a57c9f5f-1cc3-4c90-9d31-dfb2ea232512 61 fields · synced Jul 9, 2026