Posterior Mandibular Angle™

Basic Information

• Brand Name: Posterior Mandibular Angle™
• Primary DI: M724TMA8R1
• Version / Model: Size 8, Right
• Catalog Number: TMA-8R
• Company Name: IMPLANTECH ASSOCIATES, INC.
• Labeler DUNS: 784664955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-18
• Public Version: 1
• Public Version Date: 2022-03-28
• Public Version Status: New
• Public Device Record Key: 75768ed6-c0cf-476c-862e-74e9bed319ec

Device Description

Mandibular Implant

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FWP	Prosthesis, Chin, Internal	General, Plastic Surgery	878.3550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16047	Facial mandibular prosthesis	A sterile implantable device intended to be used in the functional reconstruction of non-joint mandibular (lower jaw) deficits. It is made of metal and/or polymeric materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M724TMA8R1	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K905268	000