Burnisher, Operative
Regulation 872.4565
0510(k)s in 12 months (72 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in EKJ
| Company | 510(k)s | Recalls |
|---|---|---|
| American Medical Ceramics, Inc. | 11 | 0 |
| Centrix, Inc. | 4 | 0 |
| Brevet, Inc. | 3 | 0 |
| Dentsply Intl. | 3 | 0 |
| Protector, Inc. | 3 | 0 |
| Tern Chien Ent. Co., Ltd. | 3 | 0 |
| Wen Hao, Inc. | 3 | 0 |
| Magnum Instruments, Inc. | 2 | 0 |
| Pulpdent Corp. | 2 | 0 |
| Zinnanti Surgical Instruments, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 10, 1996 | K961714 | ASEPTYLUM, UNI-CARRIER Distriflor S.A. | EKJ |
| Jan 4, 1996 | K953707 | MEDTROL DENTAL KIT Medtrol, Inc. | EKJ |
| Jul 19, 1995 | K945815 | DENTAL KIT Constancy Ent., Inc. | EKJ |
| Jun 22, 1995 | K951607 | SUREFLEX FILES Dentsply Intl. | EKJ |
| Nov 30, 1994 | K945077 | INSTRUMENT,FILLING,PLASTIC,DENTAL Worldwide Dental, Inc. | EKJ |
| Nov 2, 1994 | K943820 | STAT PAK Magnum Instruments, Inc. | EKJ |
| Oct 7, 1994 | K943351 | MAUNAL DISPOSABLE DENTAL INSTRUMENTS Magnum Instruments, Inc. | EKJ |
| Sep 21, 1994 | K943584 | PRESTERILIZED ENDODONTIC FILES Dentsply Intl. | EKJ |
| Jul 28, 1994 | K935127 | SOUTHLAND STERILE DENTAL SYSTEM Southland, Ltd. | EKJ |
| Jul 8, 1994 | K941954 | NON-FOGGING DENTAL MIRROR Buffalo Dental Mfg. Co., Inc. | EKJ |
| Jul 5, 1994 | K925115 | AMD DENTIST AND HYGIENIST KITS Advance Medical Designs, Inc. | EKJ |
| Feb 15, 1994 | K925890 | MIRROR, MOUTH Protector, Inc. | EKJ |
| Feb 15, 1994 | K925889 | FORCEPS, DRESSING, DENTAL Protector, Inc. | EKJ |
| Feb 15, 1994 | K925888 | EXPLORER, OPERATIVE Protector, Inc. | EKJ |
| Jan 5, 1994 | K935217 | LC DENTAL HAND INSTRUMENT L.C. Dental | EKJ |
| Nov 5, 1993 | K932511 | SILICONE MIRROR Moyco Industries, Inc. | EKJ |
| Sep 15, 1993 | K926368 | APPLICATOR NOZZLE Centrix, Inc. | EKJ |
| Jun 29, 1993 | K923902 | STERILE DENTAL KITS Professional Sterile Systems, Inc. | EKJ |
| Nov 4, 1992 | K922988 | ECO/DENTAL GENERAL DENTAL PACK Dyna-Pace Systems, Inc. | EKJ |
| Sep 25, 1992 | K921354 | BLUNT TIP IRRIGATION NEEDLES Innovators, Inc. | EKJ |
| Nov 13, 1991 | K914368 | PART 872 DEGUFILL H & DEGUFILL M DA Degussa AG | EKJ |
| Oct 21, 1991 | K911655 | IMPLARETTE Implant Innovations International, Inc. | EKJ |
| Jul 24, 1991 | K912473 | ACCU-PLACER TM KIT Hu-Friedy Mfg. Co., Inc. | EKJ |
| Jul 17, 1991 | K911214 | NUTIP (TM) SYRINGE SHIELD Western M/D, Inc. | EKJ |
| Jun 24, 1991 | K912149 | HARDCOATED PLASTIC FILLING INSTRUMENT Premier Dental Products Co. | EKJ |
| May 15, 1991 | K911281 | PULPDENT PIC N STIC Pulpdent Corp. | EKJ |
| May 7, 1990 | K901053 | MIRROR SHIELD Pulpdent Corp. | EKJ |
| Apr 27, 1990 | K901178 | AMALGAM CONDENSER American Medical Ceramics, Inc. | EKJ |
| Apr 16, 1990 | K901177 | DISCOID/CLEOID DOUBLE END AMALGAM CARVER American Medical Ceramics, Inc. | EKJ |
| Apr 16, 1990 | K901176 | #23 EXPLORER American Medical Ceramics, Inc. | EKJ |
| Apr 16, 1990 | K901175 | HAND MIRROR American Medical Ceramics, Inc. | EKJ |
| Apr 16, 1990 | K901174 | ELEVATOR #11 American Medical Ceramics, Inc. | EKJ |
| Apr 16, 1990 | K901173 | DISCOID SPOON EXCAVATOR American Medical Ceramics, Inc. | EKJ |
| Apr 16, 1990 | K901172 | GRACEY CURETTE #13-14 American Medical Ceramics, Inc. | EKJ |
| Apr 16, 1990 | K901171 | U-15 SINGLE END SCALER American Medical Ceramics, Inc. | EKJ |
| Apr 16, 1990 | K901170 | PERIODONTAL KNIFE American Medical Ceramics, Inc. | EKJ |
| Apr 16, 1990 | K901169 | 5 STRAIGHT SCISSORS American Medical Ceramics, Inc. | EKJ |
| Mar 6, 1990 | K896843 | EXPLORER 24 DENTAL HAND INSTRUMENT American Medical Ceramics, Inc. | EKJ |
| Feb 2, 1990 | K896565 | DMV(R) VENEER SUCTION GRIPPER Dmv Corp. | EKJ |
| Jan 10, 1990 | K895985 | SANI-PIKS DENTAL HAND INSTRUMENT Bison-Lee Co. | EKJ |
| Dec 4, 1989 | K895958 | BREVET FLOSS PICK (AUTOCLAVE STERILIZER) Brevet, Inc. | EKJ |
| Nov 29, 1989 | K895959 | BREVET FLOSS PICK (COLD STERILIZATION FLUIDS) Brevet, Inc. | EKJ |
| Oct 30, 1989 | K894897 | ANSWER DENTAL IMPLEMENT, FORCEPS Tern Chien Ent. Co., Ltd. | EKJ |
| Oct 30, 1989 | K894896 | ANSWER DENTAL IMPLEMENT, EXPLORER Tern Chien Ent. Co., Ltd. | EKJ |
| Oct 30, 1989 | K894895 | ANSWER DENTAL IMPLEMENTS, MIRROR Tern Chien Ent. Co., Ltd. | EKJ |
| May 18, 1989 | K892239 | DENTAL HAND INSTRUMENTS Implant Support Systems, Inc. | EKJ |
| May 10, 1989 | K892261 | RUBBER DAM CLAMPS/FORCEPS Zinnanti Surgical Instruments, Inc. | EKJ |
| May 2, 1989 | K892260 | PRICHARD PERIOSTEAL RETRACTOR #3 Zinnanti Surgical Instruments, Inc. | EKJ |
| Mar 31, 1989 | K884308 | MANDIBLE MANIPULATOR Leonard Medical, Inc. | EKJ |
| Feb 13, 1989 | K890357 | DENTAL IMPRESSION SYINGE Innotek Dental Corp. | EKJ |
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