EFB
DENTAL HANDPIECE
- Advisory panel
- Dental
- Total cleared
- 261
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 →
Recent clearances under product code EFB
1–100 of 261- 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)
- K241880 — Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
- K233122 — High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)
- K233308 — Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)
- K220179 — High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors
- K232243 — EVO 700 series high speed handpiece
- K230888 — Titanium Turbine
- K221741 — TRAUS Air Dental Handpiece
- K202674 — Medidenta High Speed Handpieces
- K212910 — Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
- K221548 — Dental Air Polishing Handpiece
- K221814 — OK Handpiece
- K203791 — Stainless Turbine
- K202371 — Highspeed Airturbine Handpiece
- K202786 — Dental Low-speed Handpieces and Accessories
- K193264 — Disposable High Speed Air Turbine Handpiece
- K181691 — High-speed air turbine handpiece / Low-speed air turbine handpiece
- K190509 — Lubrina 2
- K192409 — Midwest Rhino XE and Air Motor M
- K192412 — SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece
- K190508 — EVO 450 series High Speed Handpieces
- K181900 — Dental high speed handpiece, Dental low speed handpiece
- K181110 — PROPHYflex 4
- K173943 — Dental High-speed Handpiece and Accessories
- K172543 — High-speed Turbine Handpieces for Single Use
- K173465 — Concentrix MX-AC High-Speed Handpiece
- K171174 — PERIO-FLOW nozzle
- K171553 — W&H Assistina Twin
- K170236 — Dental Low-speed Turbine Handpiece
- K170229 — Dental High-speed Turbine Handpiece
- K170261 — Premium Plus Prophy Air Motor
- K163483 — PANA SPRAY Plus
- K162926 — Air-Powered Handpieces and Handpiece Attachments
- K160410 — WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head
- K153411 — 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece
- K151912 — AIR-FLOW handy 3.0 PLUS
- K152146 — High Speed Handpieces and Accessories
- K143704 — Advanced Air System
- K141886 — MDK HANDPIECES
- K141576 — Maxima PRO 45L
- K150798 — Codent Low Speed Dental Handpieces and Accessories
- K141183 — EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES
- K143183 — Maxima XTEND Handpiece Maintenance System
- K141221 — LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR
- K142063 — #8C RENEGADE DENTAL HANDPIECE
- K133069 — CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES
- K131319 — T1/T2/T3 TURBINE FAMILY
- K132478 — AIR-FLOW HANDY 3.0
- K133170 — QUICK JET M
- K132480 — AIR-FLOW HANDY 3.0 PERIO
- K130560 — MASTERTORQUE LUX 8900 L
- K130455 — 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES
- K131014 — PANA SPRAY PLUS
- K120218 — TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE)
- K112024 — TI-MAX X450
- K113674 — SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT
- K113655 — TI-MAX X TURBINE
- K113222 — ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE
- K111249 — ORTHOSLENDERIZER
- K112673 — PROPHY-MATE NEO
- K113301 — CONCENPIECE,HIGH-SPEED HANDPIECE SERIES
- K112623 — AIRLIGHT DENTAL HANDPIECE
- K112869 — EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400
- K110379 — AIR-N-GO
- K102517 — TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS
- K100731 — BOSWORTH AIR POLISHER
- K101551 — PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M
- K101717 — DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING
- K100389 — HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT
- K100833 — SYLE SMARTIP
- K093971 — DENTAL HANDPIECE
- K093341 — CENTURY MODEL 105C
- K092933 — SAF (SELF ADJUSTING FILE)
- K093072 — STARCARE HANDPIECE MAINTENANCE UNIT
- K093084 — ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP
- K092289 — EMS AIR-FLOW HANDY PERIO
- K091065 — AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
- K090548 — CONTRA-ANGLE HANDPIECE KOMET OS30
- K090369 — PRODRIVE LINE OF DENTAL HANDPIECES
- K083101 — PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES
- K082791 — EMS AIR-FLOW MASTER
- K081811 — CARE3 PLUS
- K082716 — A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43
- K082827 — A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT
- K080682 — HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE
- K073478 — SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS
- K073652 — ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE
- K080240 — CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE
- K073319 — STATMATIC 31 HANDPIECE MAINTENANCE UNIT
- K072989 — AXIS SYSTEM
- K072754 — AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE
- K073284 — AIR-FLOW MASTER STANDARD
- K073353 — DO-ALL DENTAL HANDPIECE LUBRICANT
- K072554 — ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES
- K071561 — HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D
- K071891 — STATIS DENTAL HANDPIECES
Data sourced from openFDA. This site is unofficial and independent of the FDA.