STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS— 510(k) K983574
Substantially EquivalentDentalez Group
FDA 510(k) clearance K983574 for STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS, Substantially Equivalent on 1999-01-08. Applicant: Dentalez Group. Device class: 1.
Clearance details
- Applicant
- Dentalez Group
- Product code
- Code EGS
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lancaster, PA, US
Recent devices under product code EGS
view allMore clearances from Dentalez Group
view all- K030133 — SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE
- K021378 — PORTABLE HDX INTRAORAL X-RAY
- K990844 — STARDENTAL AXCS STERILE WATER SYSTEM
- K982593 — LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE
- K960260 — STAR TITAN SERIES MOTORS & ATTACHMENTS
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.