FDA Product Code
FDA Product Code EKJ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4565
510(k) Clearances — 72 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K961714 | ASEPTYLUM, UNI-CARRIER | Distriflor S.A. | 1996-06-10 | Traditional | PDF ↗ |
| K953707 | MEDTROL DENTAL KIT | Medtrol, Inc. | 1996-01-04 | Traditional | PDF ↗ |
| K945815 | DENTAL KIT | Constancy Ent., Inc. | 1995-07-19 | Traditional | PDF ↗ |
| K951607 | SUREFLEX FILES | Dentsply Intl. | 1995-06-22 | Traditional | PDF ↗ |
| K945077 | INSTRUMENT,FILLING,PLASTIC,DENTAL | Worldwide Dental, Inc. | 1994-11-30 | Traditional | PDF ↗ |
| K943820 | STAT PAK | Magnum Instruments, Inc. | 1994-11-02 | Traditional | PDF ↗ |
| K943351 | MAUNAL DISPOSABLE DENTAL INSTRUMENTS | Magnum Instruments, Inc. | 1994-10-07 | Traditional | PDF ↗ |
| K943584 | PRESTERILIZED ENDODONTIC FILES | Dentsply Intl. | 1994-09-21 | Traditional | PDF ↗ |
| K935127 | SOUTHLAND STERILE DENTAL SYSTEM | Southland, Ltd. | 1994-07-28 | Traditional | PDF ↗ |
| K941954 | NON-FOGGING DENTAL MIRROR | Buffalo Dental Mfg. Co., Inc. | 1994-07-08 | Traditional | PDF ↗ |
| K925115 | AMD DENTIST AND HYGIENIST KITS | Advance Medical Designs, Inc. | 1994-07-05 | Traditional | PDF ↗ |
| K925890 | MIRROR, MOUTH | Protector, Inc. | 1994-02-15 | Traditional | PDF ↗ |
| K925889 | FORCEPS, DRESSING, DENTAL | Protector, Inc. | 1994-02-15 | Traditional | PDF ↗ |
| K925888 | EXPLORER, OPERATIVE | Protector, Inc. | 1994-02-15 | Traditional | PDF ↗ |
| K935217 | LC DENTAL HAND INSTRUMENT | L.C. Dental | 1994-01-05 | Traditional | PDF ↗ |
| K932511 | SILICONE MIRROR | Moyco Industries, Inc. | 1993-11-05 | Traditional | PDF ↗ |
| K926368 | APPLICATOR NOZZLE | Centrix, Inc. | 1993-09-15 | Traditional | PDF ↗ |
| K923902 | STERILE DENTAL KITS | Professional Sterile Systems, Inc. | 1993-06-29 | Traditional | PDF ↗ |
| K922988 | ECO/DENTAL GENERAL DENTAL PACK | Dyna-Pace Systems, Inc. | 1992-11-04 | Traditional | PDF ↗ |
| K921354 | BLUNT TIP IRRIGATION NEEDLES | Innovators, Inc. | 1992-09-25 | Traditional | PDF ↗ |
| K914368 | PART 872 DEGUFILL H & DEGUFILL M DA | Degussa AG | 1991-11-13 | Traditional | PDF ↗ |
| K911655 | IMPLARETTE | Implant Innovations International, Inc. | 1991-10-21 | Traditional | PDF ↗ |
| K912473 | ACCU-PLACER TM KIT | Hu-Friedy Mfg. Co., Inc. | 1991-07-24 | Traditional | PDF ↗ |
| K911214 | NUTIP (TM) SYRINGE SHIELD | Western M/D, Inc. | 1991-07-17 | Traditional | PDF ↗ |
| K912149 | HARDCOATED PLASTIC FILLING INSTRUMENT | Premier Dental Products Co. | 1991-06-24 | Traditional | PDF ↗ |
| K911281 | PULPDENT PIC N STIC | Pulpdent Corp. | 1991-05-15 | Traditional | PDF ↗ |
| K901053 | MIRROR SHIELD | Pulpdent Corp. | 1990-05-07 | Traditional | PDF ↗ |
| K901178 | AMALGAM CONDENSER | American Medical Ceramics, Inc. | 1990-04-27 | Traditional | PDF ↗ |
| K901169 | 5 STRAIGHT SCISSORS | American Medical Ceramics, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K901174 | ELEVATOR #11 | American Medical Ceramics, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K901177 | DISCOID/CLEOID DOUBLE END AMALGAM CARVER | American Medical Ceramics, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K901175 | HAND MIRROR | American Medical Ceramics, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K901173 | DISCOID SPOON EXCAVATOR | American Medical Ceramics, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K901176 | #23 EXPLORER | American Medical Ceramics, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K901171 | U-15 SINGLE END SCALER | American Medical Ceramics, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K901172 | GRACEY CURETTE #13-14 | American Medical Ceramics, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K901170 | PERIODONTAL KNIFE | American Medical Ceramics, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K896843 | EXPLORER 24 DENTAL HAND INSTRUMENT | American Medical Ceramics, Inc. | 1990-03-06 | Traditional | PDF ↗ |
| K896565 | DMV(R) VENEER SUCTION GRIPPER | Dmv Corp. | 1990-02-02 | Traditional | PDF ↗ |
| K895985 | SANI-PIKS DENTAL HAND INSTRUMENT | Bison-Lee Co. | 1990-01-10 | Traditional | PDF ↗ |
| K895958 | BREVET FLOSS PICK (AUTOCLAVE STERILIZER) | Brevet, Inc. | 1989-12-04 | Traditional | PDF ↗ |
| K895959 | BREVET FLOSS PICK (COLD STERILIZATION FLUIDS) | Brevet, Inc. | 1989-11-29 | Traditional | PDF ↗ |
| K894896 | ANSWER DENTAL IMPLEMENT, EXPLORER | Tern Chien Ent. Co., Ltd. | 1989-10-30 | Traditional | PDF ↗ |
| K894897 | ANSWER DENTAL IMPLEMENT, FORCEPS | Tern Chien Ent. Co., Ltd. | 1989-10-30 | Traditional | PDF ↗ |
| K894895 | ANSWER DENTAL IMPLEMENTS, MIRROR | Tern Chien Ent. Co., Ltd. | 1989-10-30 | Traditional | PDF ↗ |
| K892239 | DENTAL HAND INSTRUMENTS | Implant Support Systems, Inc. | 1989-05-18 | Traditional | PDF ↗ |
| K892261 | RUBBER DAM CLAMPS/FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-05-10 | Traditional | PDF ↗ |
| K892260 | PRICHARD PERIOSTEAL RETRACTOR #3 | Zinnanti Surgical Instruments, Inc. | 1989-05-02 | Traditional | PDF ↗ |
| K884308 | MANDIBLE MANIPULATOR | Leonard Medical, Inc. | 1989-03-31 | Traditional | PDF ↗ |
| K890357 | DENTAL IMPRESSION SYINGE | Innotek Dental Corp. | 1989-02-13 | Traditional | PDF ↗ |
| K890064 | DENTAL SYRINGE APPLICATION TIP | Centrix, Inc. | 1989-02-10 | Traditional | PDF ↗ |
| K884653 | RACESTYPTINE | Specialites Septodont | 1989-01-19 | Traditional | PDF ↗ |
| K885219 | DENTAL DRESSING PLIERS | Wen Hao, Inc. | 1989-01-19 | Traditional | PDF ↗ |
| K885217 | DISCARD DENTAL EXPLORER | Wen Hao, Inc. | 1989-01-19 | Traditional | PDF ↗ |
| K885218 | DISCARD DENTAL MIRROR | Wen Hao, Inc. | 1989-01-19 | Traditional | PDF ↗ |
| K884515 | BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED | Gatewood and Associates, Ltd. | 1989-01-10 | Traditional | PDF ↗ |
| K885162 | BENDA BRUSH | Centrix, Inc. | 1989-01-10 | Traditional | PDF ↗ |
| K885040 | DENTAL MIRROR RETRACTOR | Nu-Lite Retractor, Inc. | 1989-01-10 | Traditional | PDF ↗ |
| K883126 | BREVET DENTAL INSTRUMENTS | Brevet, Inc. | 1988-10-05 | Traditional | PDF ↗ |
| K882821 | VITRABOND LIGHT CURE GLASS IONOMER LINER | 3M Company | 1988-09-15 | Traditional | PDF ↗ |
| K883322 | DENTAL HAND INSTRUMENTS | Collagen Corp. | 1988-08-26 | Traditional | PDF ↗ |
| K882651 | CENTRIX NEEDLETUBE | Centrix, Inc. | 1988-08-10 | Traditional | PDF ↗ |
| K882834 | TISSUE PUNCH | Tri-Stage, Inc. | 1988-08-02 | Traditional | PDF ↗ |
| K881992 | SYRETTE | Oratec Corp. | 1988-07-26 | Traditional | PDF ↗ |
| K882309 | THE DIRECTION DIAL | Lawhorn Innovations | 1988-06-23 | Traditional | PDF ↗ |
| K882399 | ASEPTIP | Koppa Innovative Dental Products, Inc. | 1988-06-21 | Traditional | PDF ↗ |
| K880849 | EXAMIX DISPENSER | G-C Intl. Corp. | 1988-05-11 | Traditional | PDF ↗ |
| K880542 | DENTALVISION TV SYSTEM | Dentsply Intl. | 1988-05-02 | Traditional | PDF ↗ |
| K880590 | DISPOSABLE DENTAL PROBE/EXPLORER | Baxter Healthcare Corp | 1988-03-02 | Traditional | PDF ↗ |
| K874964 | DENTAL HAND INSTRUMENTS | Solway, Inc. | 1988-01-27 | Traditional | PDF ↗ |
| K874335 | EXPLORER-DENTAL PROBER | Military Engineering, Inc. | 1987-12-29 | Traditional | PDF ↗ |
| K821779 | BEACH AMALGAM CARRIER, GUN TYPE | Pacific Dental Corp. | 1982-07-06 | Traditional | PDF ↗ |
Product code EKJ · Class I · Dental. Data: openFDA.