Product code EKS

Current FDA Classification

Device name
File, Pulp Canal, Endodontic
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

Related 510(k) Records

510(k)DeviceApplicantDecision date
K062856TF ROTARY NICKEL TITANIUM FILEOrmco Corp.2006-12-13
K004031NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILESDental Power, Inc.2001-03-28
K971319NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILESTycom Dental1997-05-22
K970649HERO 642Micro-Mega1997-05-16
K962031QUANTEC SERIES 2000 ENDODONTIC FILESTycom Dental1996-06-04
K953604SHAPING HEDSTROM N.T.Sybron Dental Specialties, Inc.1995-09-28
K935542NICKEL-TITANIUM K-TYPE FILEUnion Broach, Div. Moyco Industries, Inc.1994-01-03
K932529LIGHTSPEED DENTAL HAND INSTRUMENTLightspeed Endodontics1993-11-04
K933582PROFILE SERIES 29 FILESTulsa Dental Products, Ltd.1993-10-20
K902018DENTAURUM CERAMIC DEBONDING UNITDentauraum, Inc.1991-04-03
K905461PROCEDURE KIT/ROUTINE DENTAL PROCEDURESAngiosystems, Inc.1991-03-05
K905640SOLID CORE GUTTA PERCHA CARRIERThe Hygenic Corp.1991-03-05
K901037VISIONER 21-AJ. Morita USA, Inc.1990-08-14
K897195A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)A Company, Inc.1990-05-31
K883418DE-BOND 200Scheu-Dental1989-10-24
K892861DENTAL PIKU.S. Dentek Corp.1989-09-15
K892894S-FILE, S-FINDER, S-ENGINE FILESvenska Dental Instruments AB1989-05-24
K873671COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEMColtene, Inc.1987-10-27
K864976SOLUSET CALCIUM DEMINERALIZING SOLUTIONEndo Technic Corp.1987-02-27
K864922DENTAL HANDPIECES AND ATTACHMENTE&D Dental Manufacturing Co.1987-02-19
K870177ENDOBRUSHC & S Microinstruments , Ltd.1987-02-19
K855136FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILEUnion Broach, Div. Moyco Industries, Inc.1986-03-06
K823684FILE TYPE K ENDODONTICUnited Dental Mfg., Inc.1982-12-28
K823685FILE TYPE H (HEDSTROEM) ENDODONTICUnited Dental Mfg., Inc.1982-12-28
K823318DENTAL INSTRUMENTS - EXCAVATORSMiltex, Inc.1982-11-24
K823316DENTAL INSTRUMENTS - FILESMiltex, Inc.1982-11-24
K822622ROOT CANAL FILES, TYPE H (HEDSTROMUnion Broach, Div. Moyco Industries, Inc.1982-09-28
K822621ROOT CANAL FILES, TYPE KUnion Broach, Div. Moyco Industries, Inc.1982-09-28
K812692FILES & REAMERSMiltex Instrument Co.1981-10-23
K812260DYNA TRAK ENDODONTIC PREP. INSTRUMENTInventive Technology Int'L., Inc.1981-08-25

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