LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE— 510(k) K982593

Clearance details

Applicant

Dentalez Group

Product code

Code EFB

Device class

Class 1

Regulation

21 CFR 872.4200

Advisory panel

Dental

Date received

1998-07-24

Decision date

1998-10-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lancaster, PA, US

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• K241074 — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)2024-11-12

• K030133 — SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE2003-04-29
• K021378 — PORTABLE HDX INTRAORAL X-RAY2002-06-07
• K990844 — STARDENTAL AXCS STERILE WATER SYSTEM1999-05-28
• K983574 — STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS1999-01-08
• K960260 — STAR TITAN SERIES MOTORS & ATTACHMENTS1996-03-28

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 →