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
25–48 of 261
Cleared Dec 11, 2019
EVO 450 series High Speed Handpieces
K190508
Ttbio Corp.
Dental · 285d
Cleared Dec 09, 2019
Dental high speed handpiece, Dental low speed handpiece
K181900
Foshan Cicada Dental Instrument Co, Ltd.
Dental · 511d
Cleared Apr 10, 2019
PROPHYflex 4
K181110
Kaltenbach & Voigt GmbH
Dental · 348d
Cleared Jul 24, 2018
Dental High-speed Handpiece and Accessories
K173943
Microp Technology (Taiwan), Inc.
Dental · 210d
Cleared Jul 11, 2018
High-speed Turbine Handpieces for Single Use
K172543
Beijing Dongbo Dental Handpiece Co., Ltd.
Dental · 322d
Cleared Mar 28, 2018
Concentrix MX-AC High-Speed Handpiece
K173465
Dentalez, Inc.
Dental · 140d
Cleared Aug 15, 2017
PANA SPRAY Plus
K163483
Nakanishi, Inc.
Dental · 246d
Cleared May 30, 2014
T1/T2/T3 TURBINE FAMILY
K131319
Sirona Dental Systems GmbH
Dental · 388d
Cleared Jun 20, 2012
TI-MAX X450
K112024
Nakanishi, Inc.
Dental · 341d
Cleared Mar 05, 2012
TI-MAX X TURBINE
K113655
Nakanishi, Inc.
Dental · 84d
Cleared Feb 07, 2012
PROPHY-MATE NEO
K112673
Nakanishi, Inc.
Dental · 146d
Cleared Dec 03, 2010
BOSWORTH AIR POLISHER
K100731
Harry J. Bosworth Co.
Dental · 263d
Cleared Apr 05, 2010
CENTURY MODEL 105C
K093341
Sybron Dental Specialties, Inc.
Dental · 164d
Cleared Oct 16, 2009
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
K091065
J. Morita USA, Inc.
Dental · 185d
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 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 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 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