TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis

FDA Premarket Approval P980052 S011

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

DeviceTMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis
Generic NameJoint, Temporomandibular, Implant
ApplicantTMJ CONCEPTS2233 Knoll Driveventura, CA 93003 PMA NumberP980052 Supplement NumberS011 Date Received08/22/2022 Decision Date08/31/2022 Product Code LZD  Advisory Committee Dental Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-08-22
Decision Date2022-08-31
PMAP980052
SupplementS011
Product CodeLZD 
Advisory CommitteeDental
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressTMJ CONCEPTS
2233 Knoll Drive
ventura, CA 93003 PMA NumberP980052 Supplement NumberS011 Date Received08/22/2022 Decision Date08/31/2022 Product Code LZD  Advisory Committee Dental Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Addition Of A Back-up Ethylene Oxide Sterilizer.

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

Device IDPMASupp
B0046123160 P980052 000
B0046520081 P980052 000
B0046520061 P980052 000
B0046520051 P980052 000
B0046120100 P980052 000
B0046123140 P980052 000
B0046123120 P980052 000
B0046123100 P980052 000
B0046123080 P980052 000
B0046123060 P980052 000
B0046120160 P980052 000
B0046120140 P980052 000
B0046520101 P980052 000
B0046520121 P980052 000
B0046520141 P980052 000
B0046120050 P980052 000
B004TYYNNNNM0 P980052 000
B0046120060 P980052 000
B0046120080 P980052 000
B0046523161 P980052 000
B0046523141 P980052 000
B0046523121 P980052 000
B0046523101 P980052 000
B0046523081 P980052 000
B0046523061 P980052 000
B0046520161 P980052 000
B0046120120 P980052 000
B004TYYNNNNRM0 P980052 004
B004TYYNNNNLF0 P980052 004
B004TYYNNNNLM0 P980052 004
B004TYYNNNNRF0 P980052 004
B004YYMMDDNNNNRM0 P980052 007
B004YYMMDDNNNNRF0 P980052 007
B004YYMMDDNNNNM0 P980052 007
B004YYMMDDNNNNLM0 P980052 007
B004YYMMDDNNNNLF0 P980052 007

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