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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 21 of 21

Device	Model / Reference	Registries	Class	Status
Septodont Paper Points	12870O	EUDAMED	Class IIa	Active
TotalFill® BC PointsTM Bioceramic Gutta Percha	5023125EU	EUDAMED	Class IIa	Active
Inline® Absorbent Paper Points	IP51/50	EUDAMED	Class IIa	Active
Wieder® EndoPaper+	WI53 XF	EUDAMED	Class IIa	Active
Paper Points	25911	EUDAMEDFDA UDI	Class IIa	Active
Septaline Endodontie Gutta Ponts, Color-End-Gutta, ISO-Taper, Vario-Taper	PL-SEP-33E.0015	EUDAMED	Class IIa	Active
Gutta-Percha Points	24032	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P920 20.02	EUDAMEDFDA UDI	Class IIa	Active
Centra® Endo Paper	SD53C	EUDAMED	Class IIa	Active
Direct Gutta Percha Points	200018	EUDAMED	Class IIa	Active
Inline® Absorbent Paper Points	IP51S/25	EUDAMED	Class IIa	Active
Mynol® Gutta Percha Points	MY-01103	EUDAMED	Class IIa	Active
Direct-R Gold Gutta Percha	200091	EUDAMED	Class IIa	Active
Mynol® Absorbent paper Points	MY-01301	EUDAMED	Class IIa	Active
FQ Guttapercha Points	GPFQ04.000.025	EUDAMED	Class IIa	Active
Gutta Percha Points	G906 L80.06	EUDAMED	Class IIa	Active
Apol® Pointes Papier	B56265	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 L45.04	EUDAMED	Class IIa	Active
Wieder® EndoPaper+	WI51 20	EUDAMED	Class IIa	Active
Exotec Pointes Papier Absorbantes, ISO Color, ISO Taper	EN02842	EUDAMED	Class IIa	Active
Paper Points PRED Pointes de papier sterile	67121	EUDAMED	Class IIa	Active
GuttaPercha Points	GP04.000.040	EUDAMED	Class IIa	Active
FQ Paper Points	PPFQ04.000.035	EUDAMED	Class IIa	Active
Rachelendo Gutta Percha Points	G906 L25.04	EUDAMED	Class IIa	Active
Septaline Endodontie Paper Points, Color-End-Paper, ISO-Taper, Vario-Taper	PL-SEP-33E.1030	EUDAMED	Class IIa	Active
FQ Paper Points	GPPR06.000.025	EUDAMEDFDA UDI	Class IIa	Active
GuttaPercha Points	GP02.000.015	EUDAMED	Class IIa	Active
Sure-Cord Clean	SCC-2/S50	EUDAMEDFDA UDI	Class I	Active
Mynol® Gutta Percha Points	MY-01245	EUDAMED	Class IIa	Active
Bio GP Points	G906 LB1.0FR25	EUDAMED	Class IIa	Active
TotalFill® BC Points™ Gutta Percha	5023745EU	EUDAMED	Class IIa	Active
Wieder® EndoGutta+	WI04 35	EUDAMED	Class IIa	Active
XP-4D ® Absorbent Paper Points	08.610.03.050.BC	EUDAMED	Class IIa	Active
Bio GP Points	G906 LB15.03	EUDAMED	Class IIa	Active
F360® Guttapercha Points	GPF04.000.055	EUDAMED	Class IIa	Active
Bio GP Points	G906 B20.06	EUDAMED	Class IIa	Active
Wieder® EndoGutta+	WI04 45	EUDAMED	Class IIa	Active
Gutta Percha Points	G812 90.02	EUDAMED	Class IIa	Active
Bio GP Points	G912 B/A	EUDAMED	Class IIa	Active
Direct Gutta Percha Points	200006	EUDAMED	Class IIa	Active
Bio GP Points	G906 BF4-F5	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P320 60.02	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