REST EAZY Appliance— 510(k) K172760
Substantially EquivalentInsert Molding Solutions, Inc.
FDA 510(k) clearance K172760 for REST EAZY Appliance, Substantially Equivalent on 2018-03-26. Applicant: Insert Molding Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Insert Molding Solutions, Inc.
- Product code
- Code LRK
- Device class
- Class 2
- Regulation
- 21 CFR 872.5570
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cumming, GA, US
Recent devices under product code LRK
view allMore clearances from Insert Molding Solutions, Inc.
view allAdverse events under product code LRK
product code LRK- Injury
- 246
- Malfunction
- 1,044
- Total
- 1,290
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.