Handpiece, Air-Powered, Dental
Regulation 872.4200
4510(k)s in 12 months (263 all time)
0recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in EFB
| Company | 510(k)s | Recalls |
|---|---|---|
| A-Dec, Inc. | 19 | 0 |
| Nakanishi, Inc. | 10 | 1 |
| Dentsply Intl. | 8 | 0 |
| Micro Motors, Inc. | 7 | 0 |
| Dentalez, Inc. | 6 | 0 |
| E.M.S Electro Medical Systems S.A | 6 | 0 |
| J. Morita USA, Inc. | 5 | 0 |
| Midwest | 5 | 0 |
| Mti Precision Products | 4 | 1 |
| Nsk Nakanishi, Inc. | 5 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 2, 1995 | K944710 | W&H 898 TOP LIGHT HIGHSPEED A-Dec, Inc. | EFB |
| Jun 2, 1995 | K944708 | W&H 895 TOP LIGH HIGHSPEED FIBEROPTIC SINGLE SPRAY A-Dec, Inc. | EFB |
| Mar 31, 1995 | K935676 | MICRO RSH HIGH SPEED HANDPIECE Micro Motors, Inc. | EFB |
| Mar 21, 1995 | K923780 | DENTOOL Dentool, Inc. | EFB |
| Dec 29, 1994 | K940261 | LYNX LOW-SPEED HANDPIECE Mti Precision Products | EFB |
| Dec 15, 1994 | K925678 | ATHENA HIGH SPEED HANDPIECE Athena Technology, Inc. | EFB |
| Jul 6, 1994 | K942672 | STERI-LUBE Petroleum Products of America | EFB |
| Mar 4, 1994 | K926155 | CA AND ST Dabi-Atlante America Corp. | EFB |
| Mar 4, 1994 | K926154 | HANDPIECE MODELS: MS-350;RS-350;N-270 AIR-MOTOR Dabi-Atlante America Corp. | EFB |
| Jan 31, 1994 | K925080 | TEK-LUBE Clinical Technology Corp. | EFB |
| Sep 29, 1993 | K932990 | ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP Oral-B Laboratories | EFB |
| Jul 22, 1993 | K925739 | HIGH SPEED DENTAL DRILL/HANDPIECE Feather Touch, Inc. | EFB |
| Jul 22, 1993 | K925378 | STERI-SOL SOLUTION, MODIFICATION Anodia Systems | EFB |
| Mar 31, 1993 | K924089 | OPTI-SHIELD Fuji Optical Systems, Inc. | EFB |
| Dec 21, 1992 | K922437 | HANDPIECE MODELS MS-350, RS-350; AIR MOTOR N-270 Dabi-Atlante America Corp. | EFB |
| Oct 5, 1992 | K923469 | ORALSAFE Oralsafe, Inc. | EFB |
| Aug 10, 1992 | K921564 | POLYCLEAN Medical Polymers, Inc. | EFB |
| Jul 17, 1991 | K912786 | W-H TOPAIR DENTAL HANDPIECE Sabra-The Dental Products Group | EFB |
| Jun 10, 1991 | K911937 | OSTEOMED IB DRILL Osteomed Corp. | EFB |
| May 15, 1991 | K911068 | 29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM Micro Motors, Inc. | EFB |
| Mar 11, 1991 | K905542 | LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS Lares Research, Inc. | EFB |
| Mar 7, 1991 | K905541 | LARES 757 WORKHORSE HIGHSPEED HANDPIECE Lares Research, Inc. | EFB |
| Feb 13, 1991 | K905155 | HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES Star Dental Mfg. Co. | EFB |
| Dec 21, 1990 | K904671 | QAR HANDPIECE Collagen Corp. | EFB |
| Jun 27, 1990 | K900798 | LYNX LOW-SPEED HANDPIECE Air Motors Technologies, IL | EFB |
| May 15, 1990 | K901239 | TELEDYNE GETZ'S DISPOSABLE PROPHY ANGLE Teledyne Getz | EFB |
| Apr 6, 1990 | K900093 | DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER Dentsply Intl. | EFB |
| Mar 14, 1990 | K897101 | DISPOSABLE PROPHY ANGLE AND ACCESSORIES Dentsply Intl. | EFB |
| Mar 8, 1990 | K896878 | HANDPIECE SYSTEM WITH MOTOR (SEVERAL MODELS) Micro Motors, Inc. | EFB |
| Mar 7, 1990 | K896879 | ORAL SURGERY HANDPIECE AND ATTACHMENTS Micro Motors, Inc. | EFB |
| Mar 7, 1990 | K896877 | DENTAL AIR MOTORS (SEVERAL MODELS) Micro Motors, Inc. | EFB |
| Mar 7, 1990 | K896876 | DYNATORQ DENTAL HANDPIECE ATTACHMENTS Micro Motors, Inc. | EFB |
| Feb 2, 1990 | K896361 | HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE Dentalez Group | EFB |
| Dec 18, 1989 | K895736 | LYNX-HIGH SPEED HANDPIECE Mti Precision Products | EFB |
| Oct 13, 1989 | K894606 | MICRO-AIRE HIGH SPEED DRILL (2910-000) Micro-Aire Surgical Instruments, Inc. | EFB |
| Jun 23, 1989 | K885115 | IMD 7GX Medical Dental Technology Co. | EFB |
| Jun 16, 1989 | K890433 | IMPLANT PARALLELING DEVICE (I.P.D.) J.E. Josephson, D.M.D. | EFB |
| Aug 26, 1988 | K882491 | CUTTING FLUID SYSTEM FOR DENTAL HIGH SPEED DRILLS Steri-Sol, Inc. | EFB |
| Jul 25, 1988 | K881985 | CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP Denticator | EFB |
| Jul 25, 1988 | K881974 | PROFICIENT(TM) PROPHYLAXIS ANGLE Block Drug Company, Inc. | EFB |
| Jun 22, 1988 | K882135 | AQUA DENT HANDPIECE EXTENSION AND AQUA DENT DISP. Vita Dental Co. | EFB |
| Dec 29, 1987 | K874294 | AUTOCHUCK ATTACHMENT Den-Tal-Ez Mfg Co., Inc. | EFB |
| Aug 25, 1987 | K873209 | PLAQUE-SWEEP Dentsply Intl. | EFB |
| Oct 6, 1986 | K863677 | TRADITION HIGH SPEED HANDPIECE Midwest | EFB |
| Mar 12, 1986 | K854645 | GOLD AIR, GOLD LIGHT Alpine Dental Equipment Co. | EFB |
| Mar 6, 1986 | K854697 | TUBING HANDPIECE REPLACEMENT Almore Intl., Inc. | EFB |
| Mar 25, 1985 | K850597 | MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL Micro-Aire Surgical Instruments, Inc. | EFB |
| Apr 25, 1984 | K840690 | DENTAL HANDPIECE Pen-Med Technology, Inc. | EFB |
| Jun 25, 1982 | K821715 | AM-40 SYSTEM American Midwest | EFB |
| Jun 9, 1982 | K821484 | DAWN LOW SPEED HANDPIECE SYSTEM Young Dental Manufacturing Co. 1, LLC | EFB |
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