HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE— 510(k) K896361
Substantially EquivalentDentalez Group
FDA 510(k) clearance K896361 for HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE, Substantially Equivalent on 1990-02-02. Applicant: Dentalez Group. Device class: 1.
Clearance details
- Applicant
- Dentalez Group
- Product code
- Code EFB
- 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 EFB
view all- K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)
- K251389 — High speed air turbine handpiece
- K242179 — Synea Fusion Handpieces (Intensiv & Profin)
- K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
- 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)
More 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
- K983574 — STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS
- K982593 — LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE
Adverse events under product code EFB
product code EFB- Injury
- 133
- Malfunction
- 562
- Total
- 695
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.