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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 12 of 21

Device	Model / Reference	Registries	Class	Status
Absorbent Paper Points	P912 L90.02	EUDAMED	Class IIa	Active
Paper Points	25968	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Points	G906 55.06	EUDAMEDFDA UDI	Class IIa	Active
EdgeEndo .04 Gutta Percha Points	SGP1504-1	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 B50.06	EUDAMED	Class IIa	Active
Paper Points	25957	EUDAMEDFDA UDI	Class IIa	Active
Rachelendo Paper Points	P910 L70.04	EUDAMED	Class IIa	Active
Gutta Percha Points	G910 BS/XF-M	EUDAMED	Class IIa	Active
Bio GP Points	G906 LB1.0F20.05	EUDAMED	Class IIa	Active
Bio GP Points	G906 LBX5	EUDAMED	Class IIa	Active
Gutta-Percha Points	24022	EUDAMEDFDA UDI	Class IIa	Active
F6 SkyTaper® Paper Points	PPF06.000.035	EUDAMED	Class IIa	Active
Rachelendo Paper Points	P910 LR50	EUDAMED	Class IIa	Active
Gutta Percha Points	G912 L120.02	EUDAMED	Class IIa	Active
Paper Points	25914	EUDAMEDFDA UDI	Class IIa	Active
Edge Taper Paper Points	ETPPF2-1	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G912 LB25.02	EUDAMED	Class IIa	Active
Inline® Absorbent Paper Points	IP51S/35	EUDAMED	Class IIa	Active
Procodile® Guttapercha Points	GPPR05.000.040	EUDAMEDFDA UDI	Class IIa	Active
F360® Guttapercha Points	GPF04.000.025	EUDAMED	Class IIa	Active
Gutta Percha Points	G906 10.06	EUDAMED	Class IIa	Active
TotalFill® BC PointsTM Bioceramic Gutta Percha	5023120EU	EUDAMED	Class IIa	Active
Direct Paper Points	200052	EUDAMED	Class IIa	Active
Centra® Endo Gutta	SD4930	EUDAMED	Class IIa	Active
Paper Points	25966	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 LB35.05	EUDAMEDFDA UDI	Class IIa	Active
Paper Points	PP02.000.020	EUDAMED	Class IIa	Active
Edge File X7 .06 Gutta Percha Points	X73006GP-1	EUDAMEDFDA UDI	Class IIa	Active
Exotec Pointes de Gutta Percha, ISO Color, ISO Taper	EN02020	EUDAMED	Class IIa	Active
Gutta Percha Points	G712 90.02	EUDAMED	Class IIa	Active
Absorbent Paper Points	P920 60.02	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P910 L50.06	EUDAMED	Class IIa	Active
Direct Gutta Percha Points	200011	EUDAMED	Class IIa	Active
Rachelendo Gutta Percha Points	G906 LBR50	EUDAMED	Class IIa	Active
Gutta-Percha Points	24054	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 LB1.0F50.04	EUDAMED	Class IIa	Active
Mynol® Absorbent paper Points	MY-01305	EUDAMED	Class IIa	Active
Absorbent Paper Points	P920 15.02	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P912 100.02	EUDAMEDFDA UDI	Class IIa	Active
PlanBDental® minikut® Paper Points	1670540	EUDAMEDFDA UDI	Class IIa	Active
Mynol® Absorbent paper Points	MY-01344	EUDAMED	Class IIa	Active
GuttaPercha Points	GP02.000.025	EUDAMED	Class IIa	Active
Steriblue Paper Points, Color-End-Paper, ISO-Taper, Vario-Taper	SB-PP4TP040	EUDAMED	Class IIa	Active
Edge File X7 .04 Gutta Percha Points	X73504GP-1	EUDAMEDFDA UDI	Class IIa	Active
TotalFill® BC PointsTM Bioceramic Gutta Percha	5023111EU	EUDAMED	Class IIa	Active
Sure-Seal RootTM Bio GP Points	G906 CS40.04	EUDAMED	Class IIa	Active
Rachelendo Paper Points	P910 L15.04	EUDAMED	Class IIa	Active
Gutta Percha Points	G912 110.02	EUDAMEDFDA UDI	Class IIa	Active
Edge Taper Gutta Percha Points	ETGPF3-1	EUDAMEDFDA UDI	Class IIa	Active
Centra® Endo Gutta	SD50F	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