Product Code: EKS FDA class 1 21 CFR 872.4565

File, Pulp Canal, Endodontic

Dental

The Endodontic Pulp Canal File is a fine, flexible hand instrument with a serrated or helically cut shaft used to enlarge and shape root canals by filing action against the canal walls, removing dentin to achieve the desired preparation geometry. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKS, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.

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510(k)s

FEI Numbers

160

Registration Numbers

160

Unique Applicants

Years Active

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Basic Information

Product Code: EKS
Device Class: FDA class 1
Regulation Number: 872.4565
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 31 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K062856	TF ROTARY NICKEL TITANIUM FILE	Dec 13, 2006	Substantially Equivalent	Ormco Corp.
K004031	NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES	Mar 28, 2001	Substantially Equivalent	Dental Power, Inc.
K971319	NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES	May 22, 1997	Substantially Equivalent	Tycom Dental
K970649	HERO 642	May 16, 1997	Substantially Equivalent	Micro-Mega
K962031	QUANTEC SERIES 2000 ENDODONTIC FILES	Jun 04, 1996	Substantially Equivalent	Tycom Dental
K953604	SHAPING HEDSTROM N.T.	Sep 28, 1995	Substantially Equivalent	Sybron Dental Specialties, Inc.
K935542	NICKEL-TITANIUM K-TYPE FILE	Jan 03, 1994	Substantially Equivalent	Union Broach, Div. Moyco Industries, Inc.
K932529	LIGHTSPEED DENTAL HAND INSTRUMENT	Nov 04, 1993	Substantially Equivalent	Lightspeed Endodontics
K933582	PROFILE SERIES 29 FILES	Oct 20, 1993	Substantially Equivalent	Tulsa Dental Products, Ltd.
K902018	DENTAURUM CERAMIC DEBONDING UNIT	Apr 03, 1991	Substantially Equivalent	Dentauraum, Inc.
K905640	SOLID CORE GUTTA PERCHA CARRIER	Mar 05, 1991	Substantially Equivalent	The Hygenic Corp.
K905461	PROCEDURE KIT/ROUTINE DENTAL PROCEDURES	Mar 05, 1991	Unknown	Angiosystems, Inc.
K901037	VISIONER 21-A	Aug 14, 1990	Substantially Equivalent	J. Morita USA, Inc.
K897195	A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)	May 31, 1990	Substantially Equivalent	A Company, Inc.
K883418	DE-BOND 200	Oct 24, 1989	Substantially Equivalent	Scheu-Dental
K892861	DENTAL PIK	Sep 15, 1989	Substantially Equivalent	U.S. Dentek Corp.
K892894	S-FILE, S-FINDER, S-ENGINE FILE	May 24, 1989	Substantially Equivalent	Svenska Dental Instruments AB
K873671	COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM	Oct 27, 1987	Substantially Equivalent	Coltene, Inc.
K864976	SOLUSET CALCIUM DEMINERALIZING SOLUTION	Feb 27, 1987	Substantially Equivalent	Endo Technic Corp.
K870177	ENDOBRUSH	Feb 19, 1987	Substantially Equivalent	C & S Microinstruments , Ltd.
K864922	DENTAL HANDPIECES AND ATTACHMENT	Feb 19, 1987	Substantially Equivalent	E&D Dental Manufacturing Co.
K855136	FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE	Mar 06, 1986	Substantially Equivalent	Union Broach, Div. Moyco Industries, Inc.
K823685	FILE TYPE H (HEDSTROEM) ENDODONTIC	Dec 28, 1982	Substantially Equivalent	United Dental Mfg., Inc.
K823684	FILE TYPE K ENDODONTIC	Dec 28, 1982	Substantially Equivalent	United Dental Mfg., Inc.
K823318	DENTAL INSTRUMENTS - EXCAVATORS	Nov 24, 1982	Substantially Equivalent	Miltex, Inc.
K823316	DENTAL INSTRUMENTS - FILES	Nov 24, 1982	Substantially Equivalent	Miltex, Inc.
K822622	ROOT CANAL FILES, TYPE H (HEDSTROM	Sep 28, 1982	Substantially Equivalent	Union Broach, Div. Moyco Industries, Inc.
K822621	ROOT CANAL FILES, TYPE K	Sep 28, 1982	Substantially Equivalent	Union Broach, Div. Moyco Industries, Inc.
K812692	FILES & REAMERS	Oct 23, 1981	Substantially Equivalent	Miltex Instrument Co.
K812260	DYNA TRAK ENDODONTIC PREP. INSTRUMENT	Aug 25, 1981	Substantially Equivalent	Inventive Technology Int'L., Inc.
K800293	FILE, PULP CANAL	Feb 19, 1980	Substantially Equivalent	Ipco Corp.