PMA
P930021: BIORA EMDOGAIN(R)
FDA PMA · Biologic material, dental · The Straumann Company
Key facts
| PMA number | P930021 |
|---|---|
| Trade name | BIORA EMDOGAIN(R) |
| Generic name | Biologic material, dental |
| Applicant | The Straumann Company |
| Product code | NQA |
| Approval date | Sep 30, 1996 |
| Docket number | 96M-0482 |
| Notice date | Nov 21, 1996 |
At a glance
- 10–99 Supplements
- Sep 5, 2025 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: