Composite™ ePTFE-Coated Anatomical Chin

Basic Information

• Brand Name: Composite™ ePTFE-Coated Anatomical Chin
• Primary DI: M724EPTFEACM1
• Version / Model: Size: Medium
• Catalog Number: EPTFE-AC-M
• Company Name: IMPLANTECH ASSOCIATES, INC.
• Labeler DUNS: 784664955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-26
• Public Version: 4
• Public Version Date: 2019-11-14
• Public Version Status: Update
• Public Device Record Key: 7e189f1a-dc4a-45cf-af2f-5d2b58e72cba

Device Description

Chin 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
LZK	Implant, Malar	General, Plastic Surgery	878.3550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35261	Chin prosthesis	A sterile device implanted in the soft tissue of the chin to correct chin deformities or improve facial appearance. It is usually made of a polymer material.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M724EPTFEACM1	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K002886	000