De Novo
DEN980003: DIAMOND PROBE/PERIO 2000 SYSTEM
FDA De Novo · diamond general development corp. · decided Jul 17, 1998
Key facts
| De Novo number | DEN980003 |
|---|---|
| Device name | DIAMOND PROBE/PERIO 2000 SYSTEM |
| Applicant | diamond general development corp. |
| Product code | MVH |
| Date received | May 18, 1998 |
| Decision date | Jul 17, 1998 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Dental |
| FEI number | 1833063 |
At a glance
- None Later 510(k)s citing this De Novo
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: