LogoFDA 510(k) Search
K Number
K960354
Device Name
PERMAMESH-D HYDROXYLAPATITE MATRIX
Manufacturer
CERAMED CORP.
Date Cleared
1996-03-20

(55 days)

Product Code
LZK
Regulation Number
878.3550
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Facial (malar) restoration and augmentation

Device Description

PermaMesh-D is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture.

AI/ML Overview

The provided text describes a medical device (PermaMesh-D Hydroxylapatite Matrix) and its intended use, but it does not contain information about acceptance criteria, device performance studies, or AI/software components.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is absent from the input.

The document is a 510(k) summary from 1996 for a physical implant, not a software or AI-powered diagnostic/analysis device. The questions in your prompt are geared towards evaluating AI/machine learning medical devices.

§ 878.3550 Chin prosthesis.

(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.