Sapphire Dorsal Comfort Fit— 510(k) K181416
Substantially EquivalentCrane Dental Laboratory, Inc.
FDA 510(k) clearance K181416 for Sapphire Dorsal Comfort Fit, Substantially Equivalent on 2019-09-17. Applicant: Crane Dental Laboratory, Inc..
Clearance details
- Applicant
- Crane Dental Laboratory, Inc.
- Product code
- Code LRK
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Adverse 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.