Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EGS — Predicate Candidate Screening
73 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
319 days90th percentile
73clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | Premium Plus (Dongguan) Limited | 2025-09-15 | 89 | 0 |
| K240950 | Disposable Prophy Angle | Pacific Care Limited | 2025-05-28 | 415 | 0 |
| K240183 | Star E900 Handpiece Series | Dentalez, Inc., Stardental Division | 2024-09-19 | 240 | 0 |
| K230106 | General Cutting Straight | Nakanishi, Inc. | 2023-05-24 | 131 | 0 |
| K222518 | FX Contra | Nakanishi, Inc. | 2022-11-17 | 90 | 0 |
| K220874 | Smooth Drive contra angle and straight handpieces | Lares Research | 2022-11-07 | 227 | 0 |
| K220346 | Lotus Prophy Angle | Ajk Engineering, Inc. | 2022-11-07 | 273 | 0 |
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | Micro-Nx Co., Ltd. | 2022-07-29 | 151 | 0 |
| K213139 | SURGmatic S15 L Pro | Kavo Dental GmbH | 2021-12-21 | 85 | 0 |
| K202960 | General Cutting Contra Handpiece | Nakanishi, Inc. | 2020-10-27 | 27 | 0 |
| K182892 | TRAUS Dental Handpieces | Saeshin Precision Co., Ltd. | 2019-11-26 | 407 | 0 |
| K182999 | General Cutting Contra Handpiece | Nakanishi, Inc. | 2019-04-16 | 168 | 0 |
| K181129 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2019-01-31 | 276 | 0 |
| K171436 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2018-01-05 | 234 | 0 |
| K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PRO | Bonart Co., Ltd. | 2017-07-18 | 279 | 0 |
| K162397 | Titan 3 Low Speed Angle Attachments | Dentalez, Inc. | 2017-01-19 | 146 | 0 |
| K133178 | LUXATOR LX HANDPIECE | Directa AB | 2015-11-24 | 768 | 0 |
| K143418 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2015-07-31 | 245 | 0 |
| K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Sirona Dental Systems GmbH | 2015-07-02 | 101 | 0 |
| K141125 | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE | Handpiece Headquarters | 2014-10-23 | 175 | 0 |
| K132356 | SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANA | Scican GmbH | 2014-01-31 | 186 | 0 |
| K121901 | TI-MAX Z45 | Nakanishi, Inc. | 2013-02-28 | 244 | 0 |
| K112305 | VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE | Thunder Tiger Corp. | 2012-04-17 | 250 | 0 |
| K111541 | ENDO-EXPRESS (R) HANDPIECE | Essential Dental Systems, Inc. | 2012-03-16 | 288 | 0 |
| K103697 | TORQTECH | J. Morita USA, Inc. | 2012-01-20 | 396 | 0 |
| K111532 | MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE | Anthogyr Sas | 2011-10-07 | 126 | 0 |
| K103158 | STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST | Angstrom Mfg., Inc. | 2011-02-07 | 104 | 0 |
| K103157 | DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE | Angstrom Mfg., Inc. | 2011-01-24 | 90 | 0 |
| K100854 | PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 | Premium Plus International Limited | 2010-12-09 | 258 | 0 |
| K100192 | STRONG DENTAL HANDPIECES | Saeshin Precision Co., Ltd. | 2010-02-04 | 13 | 0 |
| K092053 | MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH | Handpiece Headquarters | 2009-08-20 | 44 | 0 |
| K061897 | EXCEL CONTRA ANGLE HANDPIECE | Orthosource, Inc. | 2007-02-14 | 226 | 0 |
| K060317 | ANTHOGYR CONTRA ANGLES AND HANDPIECES | Est. Anthogyr | 2006-04-28 | 79 | 0 |
| K060377 | DR DISPOSABLE PROPHY ANGLE MODEL H310 | Dental Resources | 2006-04-26 | 71 | 0 |
| K051077 | E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 | Aseptico, Inc. | 2005-05-03 | 6 | 0 |
| K042171 | AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 5 | Micro-Mega Societe Anonyme | 2004-11-10 | 91 | 0 |
| K032925 | B&R DEVICE | Ronvig A/S | 2003-12-22 | 91 | 0 |
| K022505 | CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 505 | NOUVAG AG | 2003-10-01 | 429 | 0 |
| K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | Pac-Dent International (Suzhou), Ltd. | 2003-04-14 | 48 | 0 |
| K023953 | ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY | St. George Technology, Inc. | 2003-02-14 | 79 | 0 |
| K022264 | CLEAN 'N' OIL | Svenska Dental Instruments AB | 2002-10-02 | 82 | 0 |
| K020137 | AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRA | Aseptico, Inc. | 2002-03-04 | 47 | 0 |
| K011061 | SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-9 | W&H Dentalwerk Buermoos GmbH | 2001-06-28 | 83 | 0 |
| K994024 | EXTENDED STRAIGHT ATTACHMENT | Team Technologies, Inc. | 2000-02-03 | 69 | 0 |
| K983574 | STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS | Dentalez Group | 1999-01-08 | 87 | 0 |
| K973800 | 23:1 REDUCTION ANGLE | Midwest Dental Products Corp. | 1998-03-11 | 156 | 0 |
| K972569 | E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, IN | Nsk Nakanishi, Inc. | 1997-10-08 | 90 | 0 |
| K971350 | SERIES XE, SERIES SE, SERIES TE | Micro-Mega Societe Anonyme | 1997-06-04 | 55 | 0 |
| K962540 | E-TYPE CONTRA ANGLE NAC-E | Nsk Nakanishi, Inc. | 1996-09-12 | 76 | 0 |
| K961494 | SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 1 | Micro-Mega Societe Anonyme | 1996-06-26 | 69 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda