Patient-Fitted TMJ Reconstruction Prosthesis System

FDA Premarket Approval P980052 S007

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a manufacturing site located at tmj concepts, 6059 king drive, ventura, california 93003

DevicePatient-Fitted TMJ Reconstruction Prosthesis System
Generic NameJoint, Temporomandibular, Implant
ApplicantTMJ CONCEPTS
Date Received2019-07-11
Decision Date2020-01-10
PMAP980052
SupplementS007
Product CodeLZD 
Advisory CommitteeDental
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address TMJ CONCEPTS 2233 Knoll Drive ventura, CA 93003

Supplemental Filings

Supplement NumberDateSupplement Type
P980052Original Filing
S011 2022-08-22 30-day Notice
S010
S009 2020-12-11 Normal 180 Day Track No User Fee
S008 2020-10-27 30-day Notice
S007 2019-07-11 Normal 180 Day Track No User Fee
S006
S005 2012-07-10 Normal 180 Day Track No User Fee
S004 2009-03-03 Normal 180 Day Track No User Fee
S003
S002 2002-11-27 Normal 180 Day Track
S001 2002-01-28 Normal 180 Day Track

NIH GUDID Devices

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