EFB · Class I · 21 CFR 872.4200

FDA Product Code EFB: Handpiece, Air-powered, Dental

FDA product code EFB covers air-powered dental handpieces used for cutting, drilling, and polishing in dental procedures.

These high-speed instruments use compressed air to rotate dental burs and attachments at speeds up to 400,000 RPM for efficient tooth preparation, cavity removal, and crown and bridge preparation. They are the most widely used dental instrument in clinical practice.

EFB devices are Class I medical devices, regulated under 21 CFR 872.4200 and reviewed by the FDA Dental panel.

Leading manufacturers include A-Dec, Inc., Nakanishi, Inc. and Dentsply Intl..

261
Total
261
Cleared
166d
Avg days
1976
Since
261 devices
73–96 of 261
Cleared Jun 30, 2009
CONTRA-ANGLE HANDPIECE KOMET OS30
K090548
W&H Dentalwerk Buermoos GmbH
Dental · 120d
Cleared Feb 18, 2009
EMS AIR-FLOW MASTER
K082791
E.M.S Electro Medical Systems S.A
Dental · 148d
Cleared Jan 21, 2009
CARE3 PLUS
K081811
Nakanishi, Inc.
Dental · 209d
Cleared Jan 15, 2009
A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43
K082716
A-Dec, Inc.
Dental · 120d
Cleared Jan 07, 2009
A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT
K082827
A-Dec, Inc.
Dental · 104d
Cleared Sep 03, 2008
SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS
K073478
Sybron Dental Specialties, Inc.
Dental · 267d
Cleared Sep 10, 2007
I-SURGE
K071965
Satelec
Dental · 56d
Cleared Jul 05, 2007
A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT
K070663
A-Dec, Inc.
Dental · 118d
Cleared May 31, 2007
LUBRINA, MODEL HIM-1
K070074
J. Morita USA, Inc.
Dental · 143d
Cleared Mar 29, 2006
INTERPROXIMAL REDUCTION SYSTEM
K053368
Dentsply International
Dental · 114d
Cleared Mar 21, 2005
AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV
K043497
J. Morita USA, Inc.
Dental · 94d
Cleared Feb 16, 2005
TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE
K043498
J. Morita USA, Inc.
Dental · 61d
Cleared Dec 17, 2004
IS 40 MICROMOTOR
K042787
Satelec
Dental · 72d
Cleared Oct 22, 2004
CROMAX HIGH SPEED TURBINE HANDPIECE
K041755
J.R. Medical Technologies, Inc.
Dental · 115d
Cleared Jun 16, 2004
DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125
K041141
Dentsply Intl.
Dental · 47d
Cleared Feb 23, 2004
SIROAIR L AIR SCALER
K033812
Sirona Dental Systems GmbH
Dental · 76d
Cleared Oct 17, 2003
PROPHY-MATE
K032395
Nakanishi, Inc.
Dental · 74d
Cleared Jul 15, 2003
ESTYLUS ELECTRIC MOTOR SYSTEM
K031145
Dentsply Intl.
Dental · 96d
Cleared Jul 09, 2003
PROPHYPEARLS
K031868
Kavo America
Dental · 22d
Cleared Jun 26, 2002
KAVO QUATTROCARE
K012308
Kavo America
Dental · 338d
Cleared Nov 08, 2001
TULSA CONTRA ANGLES
K012720
Dentsply Intl.
Dental · 85d
Cleared Oct 05, 2001
W & H ASSISTINA
K010127
A-Dec, Inc.
Dental · 275d
Cleared Jan 09, 2001
RAPIDD HIGHSPEED DENTAL HANDPIECE
K003518
Dentsply Intl.
Dental · 55d
Cleared Apr 04, 2000
SUNI MAX
K000049
Satelec
Dental · 88d