MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL— 510(k) K850597
Substantially EquivalentMicro-Aire Surgical Instruments, Inc.
FDA 510(k) clearance K850597 for MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL, Substantially Equivalent on 1985-03-25. Applicant: Micro-Aire Surgical Instruments, Inc.. Device class: 1.
Clearance details
- Applicant
- Micro-Aire Surgical Instruments, Inc.
- Product code
- Code EFB
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Fernando, CA, US
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More clearances from Micro-Aire Surgical Instruments, Inc.
view allAdverse events under product code EFB
product code EFB- Injury
- 133
- Malfunction
- 562
- Total
- 695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.