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.
Approval for heat treatment of surgical instruments by solar atmospheres, located at 8606 live oak ave fontana, ca 92335.
| Device | Patient-Fitted TMJ Reconstruction Prosthesis System |
| Generic Name | Joint, Temporomandibular, Implant |
| Applicant | TMJ CONCEPTS |
| Date Received | 2020-12-11 |
| Decision Date | 2021-04-27 |
| PMA | P980052 |
| Supplement | S009 |
| Product Code | LZD |
| Advisory Committee | Dental |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TMJ CONCEPTS 2233 Knoll Drive ventura, CA 93003 |
| 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 |