DR DISPOSABLE PROPHY ANGLE MODEL H310— 510(k) K060377

Substantially Equivalent

Dental Resources

FDA 510(k) clearance K060377 for DR DISPOSABLE PROPHY ANGLE MODEL H310, Substantially Equivalent on 2006-04-26. Applicant: Dental Resources.

Clearance details

Applicant: Dental Resources
Product code: Code EGS
Advisory panel: Dental
Date received: 2006-02-14
Decision date: 2006-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Lake, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EGS

product code EGS

Injury: 356
Malfunction: 759
Total: 1,115

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.