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SURE DENT CORPORATION

South Korea·KR-MF-000018662

Last updated September 17, 2026

What SURE DENT CORPORATION makes

Sure Dent Corporation manufactures non-medicated gingival retraction cords, including variants like the R&S Retraction Cord, Kent dental Retraction Cord, and Inline-Cord. These products are designed to isolate gingival tissue during dental procedures, such as impressions or restorations, to improve accuracy and margin definition.

The company’s portfolio includes devices classified as Class I and Class IIa under EU regulations, with products registered in the EUDAMED database. The manufacturer is based in South Korea.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Sure Dent Corporation manufacture?

Sure Dent Corporation specializes in non-medicated gingival retraction cords, such as the R&S Retraction Cord, Kent dental Retraction Cord, and Inline-Cord. These devices are used in dentistry to temporarily retract gum tissue during procedures like impressions or restorations, ensuring clearer margins and better accuracy.

Where is Sure Dent Corporation based?

Sure Dent Corporation is headquartered in South Korea. The company’s location influences its regulatory compliance, particularly for markets like the European Union, where its devices are registered in the EUDAMED database.

Which regulatory registries list Sure Dent Corporation’s devices?

Sure Dent Corporation’s devices are listed in the EUDAMED database, which is the European Union’s transparency system for medical devices. This registry allows healthcare professionals and regulators to verify the manufacturer’s details and device classifications.

How are Sure Dent Corporation’s devices classified under EU regulations?

Sure Dent Corporation’s devices fall into Class I and Class IIa classifications under EU medical device regulations. The classification depends on factors like the device’s intended use and potential risk level—gingival retraction cords are generally lower-risk but may require additional scrutiny depending on design or materials.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: South Korea
Address: 52, #809, Sagimakgol-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, South Korea
Website: www.suredent.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +82 31 737 4720
PRRC Contact: Sungjun Charles Bae
EUDAMED SRN: KR-MF-000018662
FDA FEI Number: 3001421500
DUNS Number: —

Catalogue (1042)

Page 16 of 21

Device	Model / Reference	Registries	Class	Status
PlanBDental® minikut® Paper Points	1670345	EUDAMEDFDA UDI	Class IIa	Active
PlanBDental® minikut® Paper Points	1670545	EUDAMEDFDA UDI	Class IIa	Active
FQ Guttapercha Points	GPFQ04.000.055	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 LBX2	EUDAMED	Class IIa	Active
Gutta Percha Points	G906 20.04	EUDAMEDFDA UDI	Class IIa	Active
TotalFill® BC PointsTM Bioceramic Gutta Percha	5023117EU	EUDAMED	Class IIa	Active
Gutta Percha Points	G410 BS/FM	EUDAMED	Class IIa	Active
Gutta-Percha Points	24025	EUDAMEDFDA UDI	Class IIa	Active
Rachelendo Paper Points	P910 L50.06	EUDAMED	Class IIa	Active
EdgeEndo .04 Paper Points	SPP5004-1	EUDAMEDFDA UDI	Class IIa	Active
Rachelendo Gutta Percha Points	G906 LBX1	EUDAMED	Class IIa	Active
Kono® Absorbent Paper Points	BP40/50	EUDAMED	Class IIa	Active
Bio GP Points	G906 LB15-40/.05	EUDAMEDFDA UDI	Class IIa	Active
Septodont Gutta Percha	12843N	EUDAMED	Class IIa	Active
Direct Bioceramic Gutta Percha	200043	EUDAMED	Class IIa	Active
FQ Guttapercha Points	GPFQ06.000.025	EUDAMEDFDA UDI	Class IIa	Active
Inline® Gutta Percha Points	IP04/25	EUDAMED	Class IIa	Active
Centra® Endo Gutta	SD50M	EUDAMED	Class IIa	Active
Gutta Percha Points	G910 BS/FM	EUDAMED	Class IIa	Active
Direct Gutta Percha Points	200015	EUDAMED	Class IIa	Active
Sure-Cord Clean	SCC-0/S50	EUDAMEDFDA UDI	Class I	Active
Gutta-Percha Points	24026	EUDAMEDFDA UDI	Class IIa	Active
PlanBDental® minikut® Paper Points	1680560	EUDAMEDFDA UDI	Class IIa	Active
Mynol® Gutta Percha Points	MY-01264	EUDAMED	Class IIa	Active
Gutta Percha Obturator	Regular	EUDAMEDFDA UDI	Class IIa	Active
Apol® Pointes Gutta	B56830	EUDAMED	Class IIa	Active
XP-4D ® Bio GP Cones	08.600.03.025.RE	EUDAMED	Class IIa	Active
TotalFill® BC PointsTM Bioceramic Gutta Percha	5023124EU	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 L80.06	EUDAMED	Class IIa	Active
Gutta Percha Points	G912 90-140/.02	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 LB30.03	EUDAMED	Class IIa	Active
Procodile® Guttapercha Points	GPPR05.000.040	EUDAMED	Class IIa	Active
TotalFill® BC PointsTM 150 Series Bioceramic Gutta Percha	5027285EU	EUDAMED	Class IIa	Active
F6 SkyTaper® Paper Points	PPF06.000.025	EUDAMED	Class IIa	Active
Exotec Pointes de Gutta Percha, ISO Color, ISO Taper	EN02430	EUDAMED	Class IIa	Active
Wellsamed Paper Points	WPP425 ISO25 Rot	EUDAMED	Class IIa	Active
Procodile® Guttapercha Points	GPPR05.000.035	EUDAMED	Class IIa	Active
Paper Points	25922	EUDAMEDFDA UDI	Class IIa	Active
Paper Points	25910	EUDAMEDFDA UDI	Class IIa	Active
Sendoline® Paper Points	4000404	EUDAMED	Class IIa	Active
Rachelendo Paper Points	P910 L25.06	EUDAMED	Class IIa	Active
Gutta Percha Points	G906 L55.04	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 80.06	EUDAMEDFDA UDI	Class IIa	Active
Edge File X7 .06 Gutta Percha Points	X74506GP-1	EUDAMEDFDA UDI	Class IIa	Active
EndoSequence® BC PointsTM Bioceramic Gutta Percha	5023075EU	EUDAMED	Class IIa	Active
PlanBDental® minikut® Paper Points	1670325	EUDAMEDFDA UDI	Class IIa	Active
Inline® Absorbent Paper Points	IP51/20	EUDAMED	Class IIa	Active
Gutta Percha Points	G906 L50.06	EUDAMED	Class IIa	Active
EdgeEndo .06 Gutta Percha Points	SGP4006-1	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Points	G910 BS/FF	EUDAMED	Class IIa	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Sure Dent Corporation US