INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT— 510(k) K910610
Substantially EquivalentBausch & Lomb, Inc.
FDA 510(k) clearance K910610 for INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT, Substantially Equivalent on 1991-07-09. Applicant: Bausch & Lomb, Inc.. Device class: 1.
Clearance details
- Applicant
- Bausch & Lomb, 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
- Tucker, GA, US
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Adverse 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.