|
Device | Patient-Fitted TMJ Reconstruction Prosthesis System |
Generic Name | Joint, temporomandibular, implant |
Regulation Number | 872.3940 |
Applicant | TMJ CONCEPTS 2233 KNOLL DRIVE VENTURA, CA 93003 |
PMA Number | P980052 |
Supplement Number | S009 |
Date Received | 12/11/2020 |
Decision Date | 04/27/2021 |
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 Granted? | No |
Combination Product | No |
Approval Order Statement Approval for heat treatment of surgical instruments by Solar Atmospheres, located at 8606 Live Oak Ave Fontana, CA. |