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.
| Device | TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis |
| Generic Name | Joint, Temporomandibular, Implant |
| Applicant | TMJ 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 Received | 2022-08-22 |
| Decision Date | 2022-08-31 |
| PMA | P980052 |
| Supplement | S011 |
| Product Code | LZD |
| Advisory Committee | Dental |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TMJ 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. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980052 | Original 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 07613327626650 | P980052 | 000 |
| 07613327626827 | P980052 | 000 |
| 07613327626834 | P980052 | 000 |
| 07613327626841 | P980052 | 000 |
| 07613327626858 | P980052 | 000 |
| 07613327626865 | P980052 | 000 |
| 07613327626872 | P980052 | 000 |
| 07613327626889 | P980052 | 000 |
| 07613327626902 | P980052 | 000 |
| 07613327626919 | P980052 | 000 |
| 07613327626926 | P980052 | 000 |
| 07613327626896 | P980052 | 000 |
| B0046120050 | P980052 | 000 |
| 07613327626810 | P980052 | 000 |
| 07613327626803 | P980052 | 000 |
| 07613327626674 | P980052 | 000 |
| 07613327626681 | P980052 | 000 |
| 07613327626698 | P980052 | 000 |
| 07613327626704 | P980052 | 000 |
| 07613327626711 | P980052 | 000 |
| 07613327626728 | P980052 | 000 |
| 07613327626742 | P980052 | 000 |
| 07613327626759 | P980052 | 000 |
| 07613327626766 | P980052 | 000 |
| 07613327626773 | P980052 | 000 |
| 07613327626780 | P980052 | 000 |
| 07613327626797 | P980052 | 000 |
| B0046120060 | P980052 | 000 |
| B0046120080 | P980052 | 000 |
| B0046120100 | P980052 | 000 |
| B0046523101 | P980052 | 000 |
| B0046123100 | P980052 | 000 |
| B0046123120 | P980052 | 000 |
| B0046123140 | P980052 | 000 |
| B0046123160 | P980052 | 000 |
| B0046520051 | P980052 | 000 |
| B0046523081 | P980052 | 000 |
| B0046520081 | P980052 | 000 |
| B0046520101 | P980052 | 000 |
| B0046520121 | P980052 | 000 |
| B0046520141 | P980052 | 000 |
| B0046123080 | P980052 | 000 |
| B0046123060 | P980052 | 000 |
| B0046120120 | P980052 | 000 |
| B0046520061 | P980052 | 000 |
| B004TYYNNNNM0 | P980052 | 000 |
| B0046520161 | P980052 | 000 |
| B0046120140 | P980052 | 000 |
| B0046523161 | P980052 | 000 |
| B0046523141 | P980052 | 000 |
| B0046523121 | P980052 | 000 |
| B0046120160 | P980052 | 000 |
| B0046523061 | P980052 | 000 |
| B004TYYNNNNLF0 | P980052 | 004 |
| B004TYYNNNNLM0 | P980052 | 004 |
| B004TYYNNNNRM0 | P980052 | 004 |
| B004TYYNNNNRF0 | P980052 | 004 |
| B004YYMMDDNNNNRM0 | P980052 | 007 |
| B004YYMMDDNNNNLM0 | P980052 | 007 |
| B004YYMMDDNNNNRF0 | P980052 | 007 |
| B004YYMMDDNNNNM0 | P980052 | 007 |
| B004YYMMDDNNNNLF0 | P980052 | 007 |
| 07613327627800 | P980052 | 012 |
| 07613327627787 | P980052 | 012 |
| 07613327627770 | P980052 | 012 |
| 07613327627763 | P980052 | 012 |
| 07613327626605 | P980052 | 012 |
| 07613327626575 | P980052 | 012 |
| 07613327626568 | P980052 | 012 |
| 07613327626551 | P980052 | 012 |