ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP— 510(k) K093084

Substantially Equivalent

Rolence Ent., Inc.

FDA 510(k) clearance K093084 for ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP, Substantially Equivalent on 2009-12-16. Applicant: Rolence Ent., Inc..

Clearance details

Applicant: Rolence Ent., Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 2009-10-01
Decision date: 2009-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.