ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES— 510(k) K072554
Substantially EquivalentSable Industries, Inc.
FDA 510(k) clearance K072554 for ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES, Substantially Equivalent on 2007-11-14. Applicant: Sable Industries, Inc.. Device class: 1.
Clearance details
- Applicant
- Sable Industries, Inc.
- 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
- Abbreviated
- Location
- Erie, CO, 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 Sable Industries, Inc.
view allAdverse 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.