SONIBRUSH— 510(k) K935149
Substantially EquivalentAmerican Dentronics, Inc.
FDA 510(k) clearance K935149 for SONIBRUSH, Substantially Equivalent on 1994-01-31. Applicant: American Dentronics, Inc.. Device class: 1.
Clearance details
- Applicant
- American Dentronics, Inc.
- Product code
- Code JEQ
- Device class
- Class 1
- Regulation
- 21 CFR 872.6865
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Las Vegas, NV, US
Recent devices under product code JEQ
view all- K200881 — Oral-B iO Test Drive Power Brush Trial Program Kit
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- K061351 — ORAL-B SONIC COMPLETE
- K061199 — ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES
- K040416 — SONICARE ADVANCE TOOTHBRUSH, MODEL 4900
More clearances from American Dentronics, Inc.
view allAdverse events under product code JEQ
product code JEQ- Injury
- 188
- Malfunction
- 2,818
- Total
- 3,006
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.