Atlas FDA

EKJ

72 FDA 510(k) clearances · Product code

63 daysmedian time to decision
233 days90th percentile
72clearances measured

FDA profile

Official device name
Burnisher, Operative
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Medical specialty
Dental
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ASEPTYLUM, UNI-CARRIER (K961714)Distriflor S.A.1996-06-10
MEDTROL DENTAL KIT (K953707)Medtrol, Inc.1996-01-04
DENTAL KIT (K945815)Constancy Ent., Inc.1995-07-19
SUREFLEX FILES (K951607)Dentsply Intl.1995-06-22
INSTRUMENT,FILLING,PLASTIC,DENTAL (K945077)Worldwide Dental, Inc.1994-11-30
STAT PAK (K943820)Magnum Instruments, Inc.1994-11-02
MAUNAL DISPOSABLE DENTAL INSTRUMENTS (K943351)Magnum Instruments, Inc.1994-10-07
PRESTERILIZED ENDODONTIC FILES (K943584)Dentsply Intl.1994-09-21
SOUTHLAND STERILE DENTAL SYSTEM (K935127)Southland, Ltd.1994-07-28
NON-FOGGING DENTAL MIRROR (K941954)Buffalo Dental Mfg. Co., Inc.1994-07-08
AMD DENTIST AND HYGIENIST KITS (K925115)Advance Medical Designs, Inc.1994-07-05
FORCEPS, DRESSING, DENTAL (K925889)Protector, Inc.1994-02-15
EXPLORER, OPERATIVE (K925888)Protector, Inc.1994-02-15
MIRROR, MOUTH (K925890)Protector, Inc.1994-02-15
LC DENTAL HAND INSTRUMENT (K935217)L.C. Dental1994-01-05
SILICONE MIRROR (K932511)Moyco Industries, Inc.1993-11-05
APPLICATOR NOZZLE (K926368)Centrix, Inc.1993-09-15
STERILE DENTAL KITS (K923902)Professional Sterile Systems, Inc.1993-06-29
ECO/DENTAL GENERAL DENTAL PACK (K922988)Dyna-Pace Systems, Inc.1992-11-04
BLUNT TIP IRRIGATION NEEDLES (K921354)Innovators, Inc.1992-09-25
PART 872 DEGUFILL H & DEGUFILL M DA (K914368)Degussa AG1991-11-13
IMPLARETTE (K911655)Implant Innovations International, Inc.1991-10-21
ACCU-PLACER TM KIT (K912473)Hu-Friedy Mfg. Co., Inc.1991-07-24
NUTIP (TM) SYRINGE SHIELD (K911214)Western M/D, Inc.1991-07-17
HARDCOATED PLASTIC FILLING INSTRUMENT (K912149)Premier Dental Products Co.1991-06-24
PULPDENT PIC N STIC (K911281)Pulpdent Corp.1991-05-15
MIRROR SHIELD (K901053)Pulpdent Corp.1990-05-07
AMALGAM CONDENSER (K901178)American Medical Ceramics, Inc.1990-04-27
HAND MIRROR (K901175)American Medical Ceramics, Inc.1990-04-16
U-15 SINGLE END SCALER (K901171)American Medical Ceramics, Inc.1990-04-16
#23 EXPLORER (K901176)American Medical Ceramics, Inc.1990-04-16
ELEVATOR #11 (K901174)American Medical Ceramics, Inc.1990-04-16
PERIODONTAL KNIFE (K901170)American Medical Ceramics, Inc.1990-04-16
DISCOID/CLEOID DOUBLE END AMALGAM CARVER (K901177)American Medical Ceramics, Inc.1990-04-16
GRACEY CURETTE #13-14 (K901172)American Medical Ceramics, Inc.1990-04-16
DISCOID SPOON EXCAVATOR (K901173)American Medical Ceramics, Inc.1990-04-16
5 STRAIGHT SCISSORS (K901169)American Medical Ceramics, Inc.1990-04-16
EXPLORER 24 DENTAL HAND INSTRUMENT (K896843)American Medical Ceramics, Inc.1990-03-06
DMV(R) VENEER SUCTION GRIPPER (K896565)Dmv Corp.1990-02-02
SANI-PIKS DENTAL HAND INSTRUMENT (K895985)Bison-Lee Co.1990-01-10
BREVET FLOSS PICK (AUTOCLAVE STERILIZER) (K895958)Brevet, Inc.1989-12-04
BREVET FLOSS PICK (COLD STERILIZATION FLUIDS) (K895959)Brevet, Inc.1989-11-29
ANSWER DENTAL IMPLEMENT, EXPLORER (K894896)Tern Chien Ent. Co., Ltd.1989-10-30
ANSWER DENTAL IMPLEMENTS, MIRROR (K894895)Tern Chien Ent. Co., Ltd.1989-10-30
ANSWER DENTAL IMPLEMENT, FORCEPS (K894897)Tern Chien Ent. Co., Ltd.1989-10-30
DENTAL HAND INSTRUMENTS (K892239)Implant Support Systems, Inc.1989-05-18
RUBBER DAM CLAMPS/FORCEPS (K892261)Zinnanti Surgical Instruments, Inc.1989-05-10
PRICHARD PERIOSTEAL RETRACTOR #3 (K892260)Zinnanti Surgical Instruments, Inc.1989-05-02
MANDIBLE MANIPULATOR (K884308)Leonard Medical, Inc.1989-03-31
DENTAL IMPRESSION SYINGE (K890357)Innotek Dental Corp.1989-02-13
DENTAL SYRINGE APPLICATION TIP (K890064)Centrix, Inc.1989-02-10
DISCARD DENTAL EXPLORER (K885217)Wen Hao, Inc.1989-01-19
DENTAL DRESSING PLIERS (K885219)Wen Hao, Inc.1989-01-19
RACESTYPTINE (K884653)Specialites Septodont1989-01-19
DISCARD DENTAL MIRROR (K885218)Wen Hao, Inc.1989-01-19
DENTAL MIRROR RETRACTOR (K885040)Nu-Lite Retractor, Inc.1989-01-10
BENDA BRUSH (K885162)Centrix, Inc.1989-01-10
BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED (K884515)Gatewood and Associates, Ltd.1989-01-10
BREVET DENTAL INSTRUMENTS (K883126)Brevet, Inc.1988-10-05
VITRABOND LIGHT CURE GLASS IONOMER LINER (K882821)3M Company1988-09-15
DENTAL HAND INSTRUMENTS (K883322)Collagen Corp.1988-08-26
CENTRIX NEEDLETUBE (K882651)Centrix, Inc.1988-08-10
TISSUE PUNCH (K882834)Tri-Stage, Inc.1988-08-02
SYRETTE (K881992)Oratec Corp.1988-07-26
THE DIRECTION DIAL (K882309)Lawhorn Innovations1988-06-23
ASEPTIP (K882399)Koppa Innovative Dental Products, Inc.1988-06-21
EXAMIX DISPENSER (K880849)G-C Intl. Corp.1988-05-11
DENTALVISION TV SYSTEM (K880542)Dentsply Intl.1988-05-02
DISPOSABLE DENTAL PROBE/EXPLORER (K880590)Baxter Healthcare Corp1988-03-02
DENTAL HAND INSTRUMENTS (K874964)Solway, Inc.1988-01-27
EXPLORER-DENTAL PROBER (K874335)Military Engineering, Inc.1987-12-29
BEACH AMALGAM CARRIER, GUN TYPE (K821779)Pacific Dental Corp.1982-07-06

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