Disposable Prophy Angle (3399-60, 3399-090, 3399-105)— 510(k) K251869
Substantially EquivalentPremium Plus (Dongguan) Limited
FDA 510(k) clearance K251869 for Disposable Prophy Angle (3399-60, 3399-090, 3399-105), Substantially Equivalent on 2025-09-15. Applicant: Premium Plus (Dongguan) Limited.
Clearance details
- Applicant
- Premium Plus (Dongguan) Limited
- Product code
- Code EGS
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dongguan, CN
Adverse events under product code EGS
product code EGS- Injury
- 356
- Malfunction
- 759
- Total
- 1,115
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.