PMA
P800035: PERI-OSS
FDA PMA · Bone grafting material, for dental bone repair · Curasan AG
Key facts
| PMA number | P800035 |
|---|---|
| Trade name | PERI-OSS |
| Generic name | Bone grafting material, for dental bone repair |
| Applicant | Curasan AG |
| Owner/operator | curasan AG |
| Product code | LPK |
| Approval date | Mar 24, 1981 |
| Notice date | Apr 13, 1981 |
| Establishment registration | 3003771570 |
| FEI number | 3003771570 |
At a glance
- 10–99 Supplements
- Dec 8, 2003 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None 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: