Product Code: EKM FDA class 1 21 CFR 872.3850

Gutta-Percha

Dental

Gutta-Percha is a natural thermoplastic polymer derived from tropical trees, formed into standardized cones or points and used as the primary material to obturate (fill and seal) prepared root canals following endodontic treatment. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKM, regulated under 21 CFR 872.3850 in the Dental (DE) specialty.

View on FDA

510(k)s

FEI Numbers

103

Registration Numbers

103

Unique Applicants

Years Active

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Basic Information

Product Code: EKM
Device Class: FDA class 1
Regulation Number: 872.3850
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K073369	EI DOWNPAK BARRIER SLEEVES	Feb 27, 2008	Substantially Equivalent	Hu-Friedy Mfg. Co., Inc.
K070246	DOWN PAK	Feb 16, 2007	Substantially Equivalent	Endo Twinn B.V.
K051573	TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)	Jun 26, 2006	Substantially Equivalent	Dr. Howard Martin, P.A.
K042870	ENDO TWINN	Jan 11, 2005	Substantially Equivalent	Endo Twinn B.V.
K023819	FIBERFILL SGP	Mar 26, 2003	Substantially Equivalent	Pentron Clinical Technologies
K971641	ANTIBACTERIAL GUTTA PERCHA	Jul 21, 1997	Substantially Equivalent	Dr. Howard Martin, P.A.
K970134	THERMAPREP PLUS OVEN	Mar 21, 1997	Substantially Equivalent	Tulsa Dental Products, Ltd.
K931742	INJECT-R FILL	May 27, 1993	Substantially Equivalent	Union Broach, Div. Moyco Industries, Inc.
K924825	MICRODOSE RC-EZ	Mar 05, 1993	Substantially Equivalent	Unicep
K915243	TOUCH 'N HEAT MODEL 5002, MODIFICATION	Jan 21, 1992	Substantially Equivalent	Analytic Technology
K910224	THERMAPREP	Mar 29, 1991	Substantially Equivalent	Tulsa Dental Products, Ltd.
K900986	THERMAFIL ENDODONTIC OBTURATOR	Nov 13, 1990	Substantially Equivalent	Tulsa Dental Products, Ltd.
K896663	ENDO-PREP	Feb 14, 1990	Substantially Equivalent	Pulpdent Corp.
K881139	THERMAFIL ENDODONTIC OBTURATOR	Apr 07, 1988	Substantially Equivalent	Tulsa Dental Products, Ltd.
K863638	GUTTA PERCHA POINTS	Oct 30, 1986	Substantially Equivalent	Endodent, Inc.
K863411	GUTTA PERCHA	Oct 30, 1986	Substantially Equivalent	Endodent, Inc.
K862129	SET CANAL SEALER PASTE	Jul 22, 1986	Substantially Equivalent	Endo Technic Corp.
K850863	ULTRAFIL-LT (GUTTA PERCHA)	Apr 16, 1985	Substantially Equivalent	The Hygenic Corp.
K832654	HEATED GUTTA PERCHA DELIVERY SYSTEM	Sep 26, 1983	Substantially Equivalent	Unitek Corp.
K830115	PAPER POINTS	Mar 01, 1983	Substantially Equivalent	North Pacific Dental, Inc.
K830114	GUTTA PERCHA POINTS	Mar 01, 1983	Substantially Equivalent	North Pacific Dental, Inc.
K823486	TOUCH-N-HEAT MODEL 5001	Jan 18, 1983	Substantially Equivalent	Analytic Technology
K820639	OBTURATION SYSTEM KIT	Apr 09, 1982	Substantially Equivalent	U.S. Shizai Corp.