EEJ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Guard, Disk
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.6010
- Medical specialty
- Dental
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1996: 1 · 1997: 1 · 1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| S.T.P.B SOFT TISSUES PROTECTIVES BLADES (K854467) | Nortex USA, Inc. | 1986-03-12 | + Add |
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