Handpiece, Direct Drive, Ac-Powered
Regulation 872.4200
1510(k)s in 12 months (90 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in EKX
| Company | 510(k)s | Recalls |
|---|---|---|
| J. Morita USA, Inc. | 6 | 0 |
| Aseptico, Inc. | 5 | 0 |
| Osstell AB | 5 | 0 |
| Perimetrics, Inc. | 3 | 0 |
| Saeshin Precision Co., Ltd. | 3 | 0 |
| W&H Dentalwerk Buermoos GmbH | 3 | 0 |
| Advanced Technology Research (A.T.R.) S.R.L. | 2 | 0 |
| Chiron Vision Corp. | 2 | 0 |
| Dentsply Sirona | 2 | 0 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 7, 2010 | K092833 | ENDOMAX CORDLESS ENDODONTIC HANDPIECE Dentamerica | EKX |
| Dec 15, 2009 | K090931 | CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR W&H Dentalwerk Buermoos GmbH, AT | EKX |
| Dec 2, 2009 | K092614 | X-SMART EASY Dentsply Interntional | EKX |
| Oct 30, 2009 | K091913 | HI TECH IMPLANT, HT PHYSIO IMPLANT By Dental Srl, IT | EKX |
| Apr 21, 2009 | K082325 | APEXUM ABLATOR Apexum , Ltd., IL | EKX |
| Sep 26, 2008 | K082523 | OSSTELL ISQ IMPLANT STABILITY METER Osstell AB | EKX |
| Aug 29, 2008 | K072213 | PERIMETRICS PERIOMETER Perimetrics, Inc. | EKX |
| Aug 7, 2008 | K081191 | TCM ENDO 20 NOUVAG AG, CH | EKX |
| Aug 17, 2007 | K071190 | ROOT ZX II J. Morita USA, Inc. | EKX |
| Oct 17, 2006 | K063007 | POWERTOME PERIOTOME Westport Medical, Inc. | EKX |
| Mar 31, 2006 | K052515 | SIROENDO Sirona Dental Systems GmbH | EKX |
| Sep 6, 2005 | K051661 | IMPLANT HANDPIECES Sirona Dental Systems GmbH | EKX |
| May 4, 2005 | K050612 | LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE Lightspeed Technology, Inc. | EKX |
| Dec 22, 2004 | K042822 | TCM ENDO V, MODEL 1534 NOUVAG AG, CH | EKX |
| Sep 23, 2004 | K041279 | IMPLANTEO IMPLANTOLOGY MOTOR Anthogyr, FR | EKX |
| Feb 26, 2004 | K033689 | OSSTELL MENTOR RFA Integration Diagnostics, Ltd. | EKX |
| Nov 25, 2003 | K033597 | ATR 5000, LC 5000, IMPLANT SYSTEM Advanced Technology Research (A.T.R.) S.R.L., IT | EKX |
| Aug 21, 2003 | K031204 | DENTAPORT ZX J. Morita USA, Inc. | EKX |
| Jun 30, 2003 | K031540 | APEX ELECTRIC HANDPIECE SYSTEM Lares Research, Inc. | EKX |
| Mar 3, 2003 | K030163 | ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 Aseptico, Inc. | EKX |
| Nov 20, 2001 | K012944 | POWER DRIVE Mediteam AB, SE | EKX |
| Aug 9, 2001 | K003714 | OSSTELL RESONANCE FREQUENCY ANALYZER Integration Diagnostics, Ltd. | EKX |
| Sep 28, 1999 | K993188 | ENDOSTEPPER 1 Phytron- Elektronik GmbH, DE | EKX |
| May 26, 1999 | K990739 | QUANTEC-E ENDO SYSTEM Sybron Dental Specialties, Inc. | EKX |
| Mar 24, 1999 | K990682 | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) Nsk Nakanishi, Inc., JP | EKX |
| Mar 19, 1999 | K990646 | PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE Nsk Nakanishi, Inc., JP | EKX |
| Dec 21, 1998 | K983413 | MODEL MS-1 HANDPIECE Parkell, Inc. | EKX |
| Jun 4, 1997 | K970339 | TRI AUTO ZX J. Morita USA, Inc. | EKX |
| Jan 25, 1994 | K932600 | MODIFIED SITE POWER HANDPIECE II Chiron Vision Corp. | EKX |
| Jul 1, 1993 | K915634 | FRESENIUS PD+ EXCHANGE DEVICE Fresenius USA, Inc. | EKX |
| Jun 23, 1992 | K922077 | MODIFIED SITE POWER HANDPIECE Chiron Vision Corp. | EKX |
| May 28, 1991 | K905071 | MX CYCLER Dakmed, Inc. | EKX |
| Jun 23, 1987 | K872171 | PERIOTEST Siemens Medical Solutions USA, Inc. | EKX |
| May 1, 1987 | K870797 | PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE Safco Dental Supply | EKX |
| Aug 26, 1983 | K832063 | ROBIN CORDLESS HANDPIECE Kaycor Intl., Ltd. | EKX |
| Jun 25, 1982 | K821739 | J. MORITA FLEX M-3 TORX HARDPIECE Pacific Dental Corp. | EKX |
| Jan 7, 1982 | K813348 | YOSHIDA RIDO-F, MODEL LM-01 Kaycor Intl., Ltd. | EKX |
| Aug 4, 1980 | K801687 | TORX MICRO-MOTOR LOW SPEED HANDPIECE Pacific Dental Corp. | EKX |
| Apr 28, 1978 | K780646 | AIR-PWOERED COLDRILL Medishield, Inc. | EKX |
| Nov 23, 1976 | K760724 | PERITONEAL DIALYSIS SYSTEM Physio-Control Corp. | EKX |
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