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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 10 of 21

Device	Model / Reference	Registries	Class	Status
Absorbent Paper Points	P910 L45.03	EUDAMED	Class IIa	Active
PlanBDental® minikut® Gutta Percha Points	1600320	EUDAMEDFDA UDI	Class IIa	Active
Sure-Cord Plus	SCP-00	EUDAMEDFDA UDI	Class IIa	Active
Paper Points	25917	EUDAMED	Class IIa	Active
Gutta Percha Points	G906 L25.04	EUDAMED	Class IIa	Active
Bio GP Points	G906 LBF1-F3	EUDAMED	Class IIa	Active
CrownOne Paper Points	12020	EUDAMED	Class IIa	Active
Bio GP Points	G906 LBF5	EUDAMED	Class IIa	Active
Mynol® Gutta Percha Points	MY-01207	EUDAMED	Class IIa	Active
Inline® Absorbent Paper Points	IP51S/45	EUDAMED	Class IIa	Active
Sure-Cord Clean	SCC-000.0	EUDAMEDFDA UDI	Class I	Active
TotalFill® BC Points™ Gutta Percha	5023108EU	EUDAMED	Class IIa	Active
Septaline Endodontie Paper Points, Color-End-Paper, ISO-Taper, Vario-Taper	PL-SEP-33E.1420	EUDAMED	Class IIa	Active
Gutta Percha Points	G906 40.04	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P920 C/XC	EUDAMED	Class IIa	Active
Sure-Cord Clean	SCC-000/S50	EUDAMEDFDA UDI	Class I	Active
Sure-Cord Plus	SCP-000.0	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P820 20.02	EUDAMED	Class IIa	Active
Apol® Pointes Papier	B56802	EUDAMED	Class IIa	Active
Absorbent Paper Points	P320 25.02	EUDAMED	Class IIa	Active
Wieder® EndoGutta+	WI06 40	EUDAMED	Class IIa	Active
Procodile® Paper Points	PPPR06.000.030	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 LBR50	EUDAMEDFDA UDI	Class IIa	Active
Sure-Seal RootTM Bio GP Points	G906 CS30.04	EUDAMED	Class IIa	Active
Mynol® Gutta Percha Points	MY-01243	EUDAMED	Class IIa	Active
EdgeOne Fire Gutta Percha Points	EOFPRIGP-1	EUDAMEDFDA UDI	Class IIa	Active
Edge One R Gutta Percha Points	EORGPAST-1	EUDAMEDFDA UDI	Class IIa	Active
Direct Bioceramic Gutta Percha	200040	EUDAMED	Class IIa	Active
Gutta Percha Points	G912 L80.02	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 15.06	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Points	G410 BS/MF-M	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 F1	EUDAMEDFDA UDI	Class IIa	Active
Paper Points	25980	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 BF5	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Points	G906 45.06	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 B60.06	EUDAMED	Class IIa	Active
Wieder® EndoGutta+	WI06 20	EUDAMED	Class IIa	Active
Inline® Gutta Percha Points	IP04/15	EUDAMED	Class IIa	Active
Edge One R Gutta Percha Points	EORGP40-1	EUDAMEDFDA UDI	Class IIa	Active
GuttaPercha Points	GP04.000.030	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 F2	EUDAMEDFDA UDI	Class IIa	Active
GuttaPercha Points	GP02.000.030	EUDAMED	Class IIa	Active
Centra® Endo Gutta	SD4955	EUDAMED	Class IIa	Active
Kono® Gutta Percha Points	BP42/15	EUDAMED	Class IIa	Active
TotalFill® BC PelletsTM Bioceramic Gutta Percha	5023109EU	EUDAMED	Class IIa	Active
Rachelendo Gutta Percha Points	G906 L70.06	EUDAMED	Class IIa	Active
Paper Points PRED Pointes de papier steril	67102	EUDAMED	Class IIa	Active
Wellsamed Paper Points	WPP340 ISO40 Schwarz	EUDAMED	Class IIa	Active
EndoSequence® BC PointsTM Bioceramic Gutta Percha	5019517EU	EUDAMED	Class IIa	Active
Direct Gutta Percha Points	200019	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