Atlas FDA

EGS

73 FDA 510(k) clearances · Product code

91 daysmedian time to decision
319 days90th percentile
73clearances measured

FDA profile

Official device name
Handpiece, Contra- And Right-Angle Attachment, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 294 · 2022: 279 · 2023: 115 · 2024: 81 · 2025: 83 · 2026: 159
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Disposable Prophy Angle (3399-60, 3399-090, 3399-105) (K251869)Premium Plus (Dongguan) Limited2025-09-15
Disposable Prophy Angle (K240950)Pacific Care Limited2025-05-28
Star E900 Handpiece Series (K240183)Dentalez, Inc., Stardental Division2024-09-19
General Cutting Straight (K230106)Nakanishi, Inc.2023-05-24
FX Contra (K222518)Nakanishi, Inc.2022-11-17
Smooth Drive contra angle and straight handpieces (K220874)Lares Research2022-11-07
Lotus Prophy Angle (K220346)Ajk Engineering, Inc.2022-11-07
Dental Handpiece, Model CA160, CA160L, and CA500L (K220577)Micro-Nx Co., Ltd.2022-07-29
SURGmatic S15 L Pro (K213139)Kavo Dental GmbH2021-12-21
General Cutting Contra Handpiece (K202960)Nakanishi, Inc.2020-10-27
TRAUS Dental Handpieces (K182892)Saeshin Precision Co., Ltd.2019-11-26
General Cutting Contra Handpiece (K182999)Nakanishi, Inc.2019-04-16
STRONG Dental Handpieces (K181129)Saeshin Precision Co., Ltd.2019-01-31
STRONG Dental Handpieces (K171436)Saeshin Precision Co., Ltd.2018-01-05
Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) (K162856)Bonart Co., Ltd.2017-07-18
Titan 3 Low Speed Angle Attachments (K162397)Dentalez, Inc.2017-01-19
LUXATOR LX HANDPIECE (K133178)Directa AB2015-11-24
STRONG Dental Handpieces (K143418)Saeshin Precision Co., Ltd.2015-07-31
Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray (K150750)Sirona Dental Systems GmbH2015-07-02
U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE (K141125)Handpiece Headquarters2014-10-23
SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST (K132356)Scican GmbH2014-01-31
TI-MAX Z45 (K121901)Nakanishi, Inc.2013-02-28
VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES (K112305)Thunder Tiger Corp.2012-04-17
ENDO-EXPRESS (R) HANDPIECE (K111541)Essential Dental Systems, Inc.2012-03-16
TORQTECH (K103697)J. Morita USA, Inc.2012-01-20
MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE (K111532)Anthogyr Sas2011-10-07
STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER (K103158)Angstrom Mfg., Inc.2011-02-07
DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE (K103157)Angstrom Mfg., Inc.2011-01-24
PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 (K100854)Premium Plus International Limited2010-12-09
STRONG DENTAL HANDPIECES (K100192)Saeshin Precision Co., Ltd.2010-02-04
MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH (K092053)Handpiece Headquarters2009-08-20
EXCEL CONTRA ANGLE HANDPIECE (K061897)Orthosource, Inc.2007-02-14
ANTHOGYR CONTRA ANGLES AND HANDPIECES (K060317)Est. Anthogyr2006-04-28
DR DISPOSABLE PROPHY ANGLE MODEL H310 (K060377)Dental Resources2006-04-26
E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 (K051077)Aseptico, Inc.2005-05-03
AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232 (K042171)Micro-Mega Societe Anonyme2004-11-10
B&R DEVICE (K032925)Ronvig A/S2003-12-22
CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, (K022505)NOUVAG AG2003-10-01
PROANGLE DISPOSABLE PROPHY ANGLE (K030603)Pac-Dent International (Suzhou), Ltd.2003-04-14
ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE (K023953)St. George Technology, Inc.2003-02-14
CLEAN 'N' OIL (K022264)Svenska Dental Instruments AB2002-10-02
AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON (K020137)Aseptico, Inc.2002-03-04
SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 (K011061)W&H Dentalwerk Buermoos GmbH2001-06-28
EXTENDED STRAIGHT ATTACHMENT (K994024)Team Technologies, Inc.2000-02-03
STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS (K983574)Dentalez Group1999-01-08
23:1 REDUCTION ANGLE (K973800)Midwest Dental Products Corp.1998-03-11
E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION (K972569)Nsk Nakanishi, Inc.1997-10-08
SERIES XE, SERIES SE, SERIES TE (K971350)Micro-Mega Societe Anonyme1997-06-04
E-TYPE CONTRA ANGLE NAC-E (K962540)Nsk Nakanishi, Inc.1996-09-12
SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE (K961494)Micro-Mega Societe Anonyme1996-06-26
J SINGLE USE HEAD AND JD REUSABLE HANDLE (K950555)Micro-Mega Societe Anonyme1995-12-28
RITE-ANGLE DISPOSABLE PROPHY ANGLES (K954802)Ash-USA1995-11-08
ORAL PROCEDURE PACK (K950743)Transidyne General Corp.1995-03-31
PROPHYLAXIS PACK (K950773)Transidyne General Corp.1995-03-31
PROPHY PRO. (K945834)Hyman, Phelps & McNamara, P.C.1995-02-13
M4 CONTRA-ANGLE HANDPIECE (K942480)Kerr Corporation (Danbury)1995-01-27
IMKB CONTRA-ANGLES (K933639)Micro-Mega1994-09-21
BVR HIGH TORQUE HEADS (K934781)Bvr Aero Precision Corp.1994-08-05
BVR CONTRA-ANGLE HANDPIECE (K934571)Bvr Aero Precision Corp.1994-08-01
DISPOSABLE PROPHY ANGLE (K941009)Allpro, Inc.1994-06-06
DISPOSABLE PROPHYLAXIS ANGLE (K941189)Team Technologies, Inc.1994-05-16
Q3 DISPOSABLE PROPHY ANGLE (K923980)Q3 Special Products, Inc.1993-05-27
CANAL FINDER (K850294)Roseburg SA1985-06-04
FLO-PHORESIS - DESENSITIZER (K844989)Eastco, Inc.1985-04-01
AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG (K850344)Midwest1985-03-25
DENSCO PROPHY ANGLE (K821686)Teledyne Densco1982-06-25
TORX HANDPIECE CONTRA ANGLES ATTACHMENTS (K801688)Pacific Dental Corp.1980-08-04
U-STYLE ADAPTER (K800735)American Midwest1980-04-10
MW STRAIGHT ATTACHMENT (K792445)Midwest1979-12-06
PROPHYLAXIS ANGLE (K790722)Young Dental Manufacturing Co. 1, LLC1979-06-15
PROPHYLAXIS ANGLE (K780752)Young Dental Manufacturing Co. 1, LLC1978-05-26
HANDPIECE, LIFT, ENDO (K780213)Kerr Corporation (Danbury)1978-02-17
PROPHY ANGLES, R&R (K780199)Ransom and Randolph1978-02-16

Track EGS automatically

Every clearance here is in the API, with alerts when new ones post.