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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 14 of 21

Device	Model / Reference	Registries	Class	Status
Wieder® EndoGutta+	WI04 15	EUDAMED	Class IIa	Active
PlanBDental® minikut® Paper Points	1670315	EUDAMEDFDA UDI	Class IIa	Active
EndoSequence® BC PointsTM Bioceramic Gutta Percha	5019511EU	EUDAMED	Class IIa	Active
Edge Taper Gutta Percha Points	ETGPF1-1	EUDAMEDFDA UDI	Class IIa	Active
Sendoline® Gutta Percha Points	3000304	EUDAMED	Class IIa	Active
Kono® Absorbent Paper Points	BP40/55	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 F3	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Points	G906 L30.04	EUDAMED	Class IIa	Active
Gutta Percha Points	G906 L35.04	EUDAMED	Class IIa	Active
Bio GP Points	G906 LB80.04	EUDAMED	Class IIa	Active
Bio GP Points	G906 B35.04	EUDAMED	Class IIa	Active
Wieder® EndoGutta+	WI06 15-40	EUDAMED	Class IIa	Active
200064	200064	EUDAMED	Class IIa	Active
Bio GP Points	G906 LB1.0F35.04	EUDAMED	Class IIa	Active
EdgeEndo .04 Gutta Percha Points	SGP3504-1	EUDAMEDFDA UDI	Class IIa	Active
Sure-Cord Knitted Retraction Cord	SC-0	EUDAMEDFDA UDI	Class I	Active
Edge Taper Gutta Percha Points	ETGPAST-1	EUDAMEDFDA UDI	Class IIa	Active
EdgeOne Fire Gutta Percha Points	EOFMEDGP-1	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P910 45.04	EUDAMEDFDA UDI	Class IIa	Active
Wellsamed Guttapercha Points	WGP425 ISO25 Rot	EUDAMED	Class IIa	Active
Paper Points	25954	EUDAMEDFDA UDI	Class IIa	Active
Edge One R Gutta Percha Points	EORGP50-1	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P920 L25.02	EUDAMED	Class IIa	Active
Apol® Pointes Gutta	B55075	EUDAMED	Class IIa	Active
Edge .04 GP	SGP7004-1	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P812 110.02	EUDAMED	Class IIa	Active
Gutta-Percha Points	24006	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Points	G912 10.02	EUDAMEDFDA UDI	Class IIa	Active
Paper Points	25979	EUDAMEDFDA UDI	Class IIa	Active
PlanBDental® minikut® Paper Points	1670535	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Points	G712 100.02	EUDAMED	Class IIa	Active
Rachelendo Gutta Percha Points	G906 L20-45/.04	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 40.06	EUDAMEDFDA UDI	Class IIa	Active
Rachelendo Paper Points	P910 L80.04	EUDAMED	Class IIa	Active
Centra® Endo Paper	SD5135	EUDAMED	Class IIa	Active
Absorbent Paper Points	P920 80.02	EUDAMEDFDA UDI	Class IIa	Active
Paper Points	25978	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 BF4	EUDAMEDFDA UDI	Class IIa	Active
Gutta-Percha Points	24030	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P910 25.06	EUDAMEDFDA UDI	Class IIa	Active
Rachelendo Gutta Percha Points	G906 LBX4	EUDAMED	Class IIa	Active
Bio GP Points	G906 B50-90/.04	EUDAMED	Class IIa	Active
Paper Points	PP02.000.030	EUDAMED	Class IIa	Active
Absorbent Paper Points	P920 L80.02	EUDAMED	Class IIa	Active
Rachelendo Gutta Percha Points	G906 LBF1	EUDAMED	Class IIa	Active
Bio GP Points	G906 LB15.05	EUDAMEDFDA UDI	Class IIa	Active
Septaline Endodontie Gutta Ponts, Color-End-Gutta, ISO-Taper, Vario-Taper	PL-SEP-33E.04ASP	EUDAMED	Class IIa	Active
PlanBDental® minikut® Gutta Percha Points	1600520	EUDAMEDFDA UDI	Class IIa	Active
TotalFill® BC PointsTM Bioceramic Gutta Percha	5023129EU	EUDAMED	Class IIa	Active
Absorbent Paper Points	P912 110.02	EUDAMEDFDA UDI	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