DZH
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Saw, Bone, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.4120
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2003: 1 · 2004: 2 · 2007: 6 · 2008: 5 · 2009: 4 · 2010: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DENTATUS OSCIOMAT (K031793) | Dentatus USA , Ltd. | 2003-11-13 |
| ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS (K935443) | Osada Electric Co., Ltd. | 1994-09-20 |
| SURGICAL OSCILLATING SAW (K760958) | American Safety Equipment Corp. | 1976-11-16 |
| SURGICAL RECIPROCATING SAW (K760957) | American Safety Equipment Corp. | 1976-11-15 |
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Every clearance here is in the API, with alerts when new ones post.