| CLASSIFICATION | Market |
| MARKETER'S COUNTRY | USA |
| PRODUCER'S COUNTRY | USA |
| STATUS |
In 12.98 FDA required all producers of TMD implants who want to remain in marketplace to submit data showing safety & efficacy. Despite the limited data submitted with these PMA's, the FDA's Dental Prodts Panel recommended to "BE FOUND APPROVABLE" with various conditions. According to an FDA official, the product will remain in market & available to patients who wants it ybtil FDA decides on the PMA's. The Co.'s prodt was cleared in 07.76 through the "substantial- equiv." route |
| UPDATE | 06.99 |
| MARKETING BY | This data is not available for free |
| PRODUCTION BY | This data is not available for free |
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