Product code EKJ
- Device name
- Burnisher, Operative
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4565
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K961714 | ASEPTYLUM, UNI-CARRIER | Distriflor S.A. | 1996-06-10 |
| K953707 | MEDTROL DENTAL KIT | Medtrol, Inc. | 1996-01-04 |
| K945815 | DENTAL KIT | Constancy Ent., Inc. | 1995-07-19 |
| K951607 | SUREFLEX FILES | Dentsply Intl. | 1995-06-22 |
| K945077 | INSTRUMENT,FILLING,PLASTIC,DENTAL | Worldwide Dental, Inc. | 1994-11-30 |
| K943820 | STAT PAK | Magnum Instruments, Inc. | 1994-11-02 |
| K943351 | MAUNAL DISPOSABLE DENTAL INSTRUMENTS | Magnum Instruments, Inc. | 1994-10-07 |
| K943584 | PRESTERILIZED ENDODONTIC FILES | Dentsply Intl. | 1994-09-21 |
| K935127 | SOUTHLAND STERILE DENTAL SYSTEM | Southland, Ltd. | 1994-07-28 |
| K941954 | NON-FOGGING DENTAL MIRROR | Buffalo Dental Mfg. Co., Inc. | 1994-07-08 |
| K925115 | AMD DENTIST AND HYGIENIST KITS | Advance Medical Designs, Inc. | 1994-07-05 |
| K925889 | FORCEPS, DRESSING, DENTAL | Protector, Inc. | 1994-02-15 |
| K925888 | EXPLORER, OPERATIVE | Protector, Inc. | 1994-02-15 |
| K925890 | MIRROR, MOUTH | Protector, Inc. | 1994-02-15 |
| K935217 | LC DENTAL HAND INSTRUMENT | L.C. Dental | 1994-01-05 |
| K932511 | SILICONE MIRROR | Moyco Industries, Inc. | 1993-11-05 |
| K926368 | APPLICATOR NOZZLE | Centrix, Inc. | 1993-09-15 |
| K923902 | STERILE DENTAL KITS | Professional Sterile Systems, Inc. | 1993-06-29 |
| K922988 | ECO/DENTAL GENERAL DENTAL PACK | Dyna-Pace Systems, Inc. | 1992-11-04 |
| K921354 | BLUNT TIP IRRIGATION NEEDLES | Innovators, Inc. | 1992-09-25 |
| K914368 | PART 872 DEGUFILL H & DEGUFILL M DA | Degussa AG | 1991-11-13 |
| K911655 | IMPLARETTE | Implant Innovations International, Inc. | 1991-10-21 |
| K912473 | ACCU-PLACER TM KIT | Hu-Friedy Mfg. Co., Inc. | 1991-07-24 |
| K911214 | NUTIP (TM) SYRINGE SHIELD | Western M/D, Inc. | 1991-07-17 |
| K912149 | HARDCOATED PLASTIC FILLING INSTRUMENT | Premier Dental Products Co. | 1991-06-24 |
| K911281 | PULPDENT PIC N STIC | Pulpdent Corp. | 1991-05-15 |
| K901053 | MIRROR SHIELD | Pulpdent Corp. | 1990-05-07 |
| K901178 | AMALGAM CONDENSER | American Medical Ceramics, Inc. | 1990-04-27 |
| K901169 | 5 STRAIGHT SCISSORS | American Medical Ceramics, Inc. | 1990-04-16 |
| K901172 | GRACEY CURETTE #13-14 | American Medical Ceramics, Inc. | 1990-04-16 |
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| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07898506843459 | Quinelato | Schobell Industrial Ltda | 2022-12-08 |
| 07898506811656 | Quinelato | Schobell Industrial Ltda | 2022-12-08 |
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